ABSORBABLE GELATIN

Description of Event or Problem

EVENT VERBATIM [PREFERRED TERM] TAE WAS PERFORMED USING A GELATIN SPONGE [OFF LABEL USE], TAE WAS PERFORMED USING A GELATIN SPONGE [DEVICE USE ISSUE], BLADDER ISCHEMIA AND EMPHYSEMATOUS CYSTITIS AFTER PERFORMING TAE/DIAGNOSIS OF EMPHYSEMATOUS CYSTITIS DUE TO ISCHEMIA AFTER TAE [ISCHAEMIA], BLADDER ISCHEMIA AND EMPHYSEMATOUS CYSTITIS AFTER PERFORMING TAE/DIAGNOSIS OF EMPHYSEMATOUS CYSTITIS DUE TO ISCHEMIA AFTER TAE [EMPHYSEMATOUS CYSTITIS], , NARRATIVE: THIS IS A LITERATURE REPORT FOR THE FOLLOWING LITERATURE SOURCE(S): "A CASE OF BLADDER ISCHEMIA AND EMPHYSEMATOUS CYSTITIS AFTER PERFORMING TAE FOR PELVIC FRACTURE", THE 53RD ANNUAL MEETING OF THE JAPANESE ASSOCIATION FOR ACUTE MEDICINE, 2025; VOL:53RD, PGS:1878. A FEMALE PATIENT IN HER 80'S RECEIVED ABSORBABLE GELATIN (ABSORBABLE GELATIN), FOR THERAPEUTIC EMBOLISATION. THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDED: "DIABETES MELLITUS" (UNSPECIFIED IF ONGOING); "PELVIC FRACTURE" (UNSPECIFIED IF ONGOING), NOTES: FRACTURES IN THE RIGHT ILIUM AND HIP BONE, RIGHT SACRAL ALA, AND LEFT PUBIC AND ISCHIAL BONES; "COLLIDED WITH A LIGHT AUTOMOBILE WHILE RIDING A MOTORIZED BICYCLE" (UNSPECIFIED IF ONGOING). THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE FOLLOWING INFORMATION WAS REPORTED: OFF LABEL USE (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), DEVICE USE ISSUE (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "RECOVERING" AND ALL DESCRIBED AS "TAE WAS PERFORMED USING A GELATIN SPONGE"; ISCHAEMIA (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), EMPHYSEMATOUS CYSTITIS (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "RECOVERING" AND ALL DESCRIBED AS "BLADDER ISCHEMIA AND EMPHYSEMATOUS CYSTITIS AFTER PERFORMING TAE/DIAGNOSIS OF EMPHYSEMATOUS CYSTITIS DUE TO ISCHEMIA AFTER TAE". THE PATIENT UNDERWENT THE FOLLOWING LABORATORY TESTS AND PROCEDURES: BLOOD PRESSURE MEASUREMENT: 164/94 MMHG; COMPUTERISED TOMOGRAM: CONTRAST AGENT EXTRAVASATION AROUND PUBIC FRACTURE; INTRAMURAL EMPHYSEMA OF THE BLADDER, NOTES: AND A RETROPERITONEAL ABSCESS WERE NOTED, LEADING TO A DIAGNOSIS OF EMPHYSEMATOUS CYSTITIS DUE TO ISCHEMIA AFTER TAE; HEART RATE: 88, NOTES: BPM; X-RAY OF PELVIS AND HIP: FRACTURES IN THE RIGHT ILIUM AND HIP BONE, NOTES: RIGHT SACRAL ALA, AND LEFT PUBIC AND ISCHIAL BONES. THE ACTION TAKEN FOR ABSORBABLE GELATIN WAS UNKNOWN. THERAPEUTIC MEASURES WERE TAKEN AS A RESULT OF ISCHAEMIA, EMPHYSEMATOUS CYSTITIS. CLINICAL COURSE: THE PATIENT HAD A HISTORY OF DIABETES MELLITUS. WHILE RIDING A MOTORIZED BICYCLE, SHE COLLIDED WITH A LIGHT AUTOMOBILE AND WAS TRANSPORTED BY AMBULANCE. VITAL SIGNS AT THE INITIAL EXAMINATION WERE BLOOD PRESSURE 164/94 MMHG AND PULSE RATE 88 BPM. PELVIC X-RAY SHOWED FRACTURES IN THE RIGHT ILIUM AND HIP BONE, RIGHT SACRAL ALA, AND LEFT PUBIC AND ISCHIAL BONES, AND CONTRAST-ENHANCED CT SHOWED IMAGES OF CONTRAST AGENT EXTRAVASATION AROUND THE PUBIC FRACTURE. TAE WAS PERFORMED USING A GELATIN SPONGE FROM THE DISTAL SIDE OF THE SUPERIOR GLUTEAL ARTERY BRANCHES OF THE BILATERAL INTERNAL ILIAC ARTERIES. ON DAY 6 OF ILLNESS, THE PATIENT HAD PYREXIA AND BLOOD PRESSURE DECREASED, AND WHEN CONTRAST-ENHANCED CT WAS PERFORMED AGAIN, INTRAMURAL EMPHYSEMA OF THE BLADDER AND A RETROPERITONEAL ABSCESS WERE NOTED, LEADING TO A DIAGNOSIS OF EMPHYSEMATOUS CYSTITIS DUE TO ISCHEMIA AFTER TAE. CONSERVATIVE TREATMENT WITH CFPM WAS STARTED ON THE SAME DAY. THERE WAS NO PROGRESSION TO BLADDER NECROSIS OR PERFORATION, AND THE ABSCESS TENDED TO SHRINK, AND ANTIMICROBIAL AGENTS WERE COMPLETED ON DAY 77 OF ILLNESS. SUBSEQUENTLY, THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR REHABILITATION ON DAY 89 OF ILLNESS. CAUSALITY FOR "TAE WAS PERFORMED USING A GELATIN SPONGE" AND "BLADDER ISCHEMIA AND EMPHYSEMATOUS CYSTITIS AFTER PERFORMING TAE/DIAGNOSIS OF EMPHYSEMATOUS CYSTITIS DUE TO ISCHEMIA AFTER TAE" WAS DETERMINED ASSOCIATED TO ABSORBABLE GELATIN (MALFUNCTION). FOLLOW-UP (17NOV2025): THIS IS A SPONTANEOUS FOLLOW-UP REPORT OBTAINED FROM PRODUCT QUALITY GROUP. UPDATED INFORMATION: UPDATED DEVICE PROBLEM CODE AND HEALTH IMPACT CODE., COMMENT: BASED ON THE AVAILABLE INFORMATION AND CONSIDERING THE PLAUSIBLE DRUG-EVENT TEMPORAL ASSOCIATION, A CONTRIBUTORY ROLE OF THE SUSPECT PRODUCT ABSORBABLE GELATIN TO THE REPORTED EVENTS ISCHAEMIA AND EMPHYSEMATOUS CYSTITIS CANNOT BE EXCLUDED. IT WAS REPORTED THAT "AFTER TRANSCATHETER ARTERIAL EMBOLIZATION (TAE), BLADDER ISCHEMIA DEVELOPED, REQUIRING LONG-TERM ANTIMICROBIAL THERAPY. PROCEDURAL FACTORS SUCH AS BACKGROUND ILLNESS AND THE PARTICLE SIZE OF THE GELATIN SPONGE USED FOR EMBOLIZATION MAY HAVE CONTRIBUTED TO THE ONSET". CASE WILL BE REASSESSED UPON RECEIPT OF ADDITIONAL INFORMATION. THE IMPACT OF THIS REPORT ON THE BENEFIT/RISK PROFILE OF THE PFIZER PRODUCT IS EVALUATED AS PART OF PFIZER PROCEDURES FOR SAFETY EVALUATION, INCLUDING THE REVIEW AND ANALYSIS OF AGGREGATE DATA FOR ADVERSE EVENTS. ANY SAFETY CONCERN IDENTIFIED AS PART OF THIS REVIEW, AS WELL AS ANY APPROPRIATE ACTION IN RESPONSE, WILL BE PROMPTLY NOTIFIED TO REGULATORY AUTHORITIES, ETHICS COMMITTEES AND INVESTIGATORS, AS APPROPRIATE.

Additional Manufacturer Narrative

INVESTIGATION SUMMARY AND CONCLUSION: (B)(4) THE COMPLAINT FOR 'ADVERSE EVENT MD/MDCP' FOR AN UNKNOWN BATCH OF GELFOAM ABSORBABLE MATERIAL WAS INVESTIGATED. THE INVESTIGATION INCLUDED REVIEWING APRRS FOR THE PRODUCT AND A MEDICAL DEVICE TREND REVIEW. THE FINAL SCOPE WAS DETERMINED TO BE ALL BATCHES OF GELFOAM MANUFACTURED BY PFIZER KALAMAZOO WITHIN THE 36 MONTHS (THE EXPIRY INTERVAL OF THE PRODUCT) PRIOR TO THE RECEIPT DATE OF THE COMPLAINT. A COMPLAINT SAMPLE WAS NOT RETURNED. NO RELATED QUALITY ISSUES WERE IDENTIFIED DURING THE INVESTIGATION. NO ROOT CAUSE OR CAPA WERE IDENTIFIED AS THE COMPLAINT WAS NOT CONFIRMED. NO RELATED QUALITY DEFECTS WERE IDENTIFIED THROUGH INVESTIGATION. THERE IS NO IMPACT ON MEDICAL DEVICE QUALITY, REGULATORY, VALIDATION, OR STABILITY. (B)(4) THIS RECORD SHOULD BE CANCELLED BECAUSE THE PRODUCT IS OUT OF SCOPE FOR DEVICE ENGINEERING INVESTIGATIONS.

Description of Event or Problem

EVENT VERBATIM [PREFERRED TERM] TAE WAS PERFORMED USING A GELATIN SPONGE [OFF LABEL USE], TAE WAS PERFORMED USING A GELATIN SPONGE [DEVICE USE ISSUE], BLADDER ISCHEMIA AND EMPHYSEMATOUS CYSTITIS AFTER PERFORMING TAE/DIAGNOSIS OF EMPHYSEMATOUS CYSTITIS DUE TO ISCHEMIA AFTER TAE [ISCHAEMIA], BLADDER ISCHEMIA AND EMPHYSEMATOUS CYSTITIS AFTER PERFORMING TAE/DIAGNOSIS OF EMPHYSEMATOUS CYSTITIS DUE TO ISCHEMIA AFTER TAE [EMPHYSEMATOUS CYSTITIS], NARRATIVE: THIS IS A LITERATURE REPORT FROM PRODUCT QUALITY GROUP FOR THE FOLLOWING LITERATURE SOURCE(S): "A CASE OF BLADDER ISCHEMIA AND EMPHYSEMATOUS CYSTITIS AFTER PERFORMING TAE FOR PELVIC FRACTURE", THE 53RD ANNUAL MEETING OF THE JAPANESE ASSOCIATION FOR ACUTE MEDICINE, 2025; VOL:53RD, PGS:1878. A FEMALE PATIENT IN HER 80'S RECEIVED ABSORBABLE GELATIN (ABSORBABLE GELATIN), FOR THERAPEUTIC EMBOLISATION. THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDED: "DIABETES MELLITUS" (ONGOING); "PELVIC FRACTURE" (UNSPECIFIED IF ONGOING), NOTES: FRACTURES IN THE RIGHT ILIUM AND HIP BONE, RIGHT SACRAL ALA, AND LEFT PUBIC AND ISCHIAL BONES; "COLLIDED WITH A LIGHT AUTOMOBILE WHILE RIDING A MOTORIZED BICYCLE" (UNSPECIFIED IF ONGOING). THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE FOLLOWING INFORMATION WAS REPORTED: OFF LABEL USE (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), DEVICE USE ISSUE (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "RECOVERING" AND ALL DESCRIBED AS "TAE WAS PERFORMED USING A GELATIN SPONGE"; ISCHAEMIA (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), EMPHYSEMATOUS CYSTITIS (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "RECOVERING" AND ALL DESCRIBED AS "BLADDER ISCHEMIA AND EMPHYSEMATOUS CYSTITIS AFTER PERFORMING TAE/DIAGNOSIS OF EMPHYSEMATOUS CYSTITIS DUE TO ISCHEMIA AFTER TAE". THE PATIENT UNDERWENT THE FOLLOWING LABORATORY TESTS AND PROCEDURES: BLOOD PRESSURE MEASUREMENT: 164/94 MMHG; COMPUTERISED TOMOGRAM: CONTRAST AGENT EXTRAVASATION AROUND PUBIC FRACTURE; INTRAMURAL EMPHYSEMA OF THE BLADDER, NOTES: AND A RETROPERITONEAL ABSCESS WERE NOTED, LEADING TO A DIAGNOSIS OF EMPHYSEMATOUS CYSTITIS DUE TO ISCHEMIA AFTER TAE; HEART RATE: 88, NOTES: BPM; X-RAY OF PELVIS AND HIP: FRACTURES IN THE RIGHT ILIUM AND HIP BONE,, NOTES: RIGHT SACRAL ALA, AND LEFT PUBIC AND ISCHIAL BONES. THE ACTION TAKEN FOR ABSORBABLE GELATIN WAS UNKNOWN. THERAPEUTIC MEASURES WERE TAKEN AS A RESULT OF ISCHAEMIA, EMPHYSEMATOUS CYSTITIS. CLINICAL COURSE: THE PATIENT HAD A HISTORY OF DIABETES MELLITUS. WHILE RIDING A MOTORIZED BICYCLE, SHE COLLIDED WITH A LIGHT AUTOMOBILE AND WAS TRANSPORTED BY AMBULANCE. VITAL SIGNS AT THE INITIAL EXAMINATION WERE BLOOD PRESSURE 164/94 MMHG AND PULSE RATE 88 BPM. PELVIC X-RAY SHOWED FRACTURES IN THE RIGHT ILIUM AND HIP BONE, RIGHT SACRAL ALA, AND LEFT PUBIC AND ISCHIAL BONES, AND CONTRAST-ENHANCED CT SHOWED IMAGES OF CONTRAST AGENT EXTRAVASATION AROUND THE PUBIC FRACTURE. TAE WAS PERFORMED USING A GELATIN SPONGE FROM THE DISTAL SIDE OF THE SUPERIOR GLUTEAL ARTERY BRANCHES OF THE BILATERAL INTERNAL ILIAC ARTERIES. ON DAY 6 OF ILLNESS, THE PATIENT HAD PYREXIA AND BLOOD PRESSURE DECREASED, AND WHEN CONTRAST-ENHANCED CT WAS PERFORMED AGAIN, INTRAMURAL EMPHYSEMA OF THE BLADDER AND A RETROPERITONEAL ABSCESS WERE NOTED, LEADING TO A DIAGNOSIS OF EMPHYSEMATOUS CYSTITIS DUE TO ISCHEMIA AFTER TAE. CONSERVATIVE TREATMENT WITH CFPM WAS STARTED ON THE SAME DAY. THERE WAS NO PROGRESSION TO BLADDER NECROSIS OR PERFORATION, AND THE ABSCESS TENDED TO SHRINK, AND ANTIMICROBIAL AGENTS WERE COMPLETED ON DAY 77 OF ILLNESS. SUBSEQUENTLY, THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR REHABILITATION ON DAY 89 OF ILLNESS. PRODUCT QUALITY GROUP PROVIDED INVESTIGATIONAL RESULTS ON 30DEC2025 FOR ABSORBABLE GELATIN: INVESTIGATION SUMMARY AND CONCLUSION: (B)(4) THE COMPLAINT FOR 'ADVERSE EVENT MD/MDCP' FOR AN UNKNOWN BATCH OF GELFOAM ABSORBABLE MATERIAL WAS INVESTIGATED. THE INVESTIGATION INCLUDED REVIEWING APRRS FOR THE PRODUCT AND A MEDICAL DEVICE TREND REVIEW. THE FINAL SCOPE WAS DETERMINED TO BE ALL BATCHES OF GELFOAM MANUFACTURED BY PFIZER KALAMAZOO WITHIN THE 36 MONTHS (THE EXPIRY INTERVAL OF THE PRODUCT) PRIOR TO THE RECEIPT DATE OF THE COMPLAINT. A COMPLAINT SAMPLE WAS NOT RETURNED. NO RELATED QUALITY ISSUES WERE IDENTIFIED DURING THE INVESTIGATION. NO ROOT CAUSE OR CAPA WERE IDENTIFIED AS THE COMPLAINT WAS NOT CONFIRMED. NO RELATED QUALITY DEFECTS WERE IDENTIFIED THROUGH INVESTIGATION. THERE IS NO IMPACT ON MEDICAL DEVICE QUALITY, REGULATORY, VALIDATION, OR STABILITY. (B)(4) THIS RECORD SHOULD BE CANCELLED BECAUSE THE PRODUCT IS OUT OF SCOPE FOR DEVICE ENGINEERING INVESTIGATIONS. CAUSALITY FOR "TAE WAS PERFORMED USING A GELATIN SPONGE" AND "BLADDER ISCHEMIA AND EMPHYSEMATOUS CYSTITIS AFTER PERFORMING TAE/DIAGNOSIS OF EMPHYSEMATOUS CYSTITIS DUE TO ISCHEMIA AFTER TAE" WAS DETERMINED ASSOCIATED TO ABSORBABLE GELATIN (MALFUNCTION). FOLLOW-UP (17NOV2025): THIS IS A SPONTANEOUS FOLLOW-UP REPORT OBTAINED FROM PRODUCT QUALITY GROUP. UPDATED INFORMATION: UPDATED DEVICE PROBLEM CODE AND HEALTH IMPACT CODE. FOLLOW-UP (30DEC2025): THIS IS A FOLLOW-UP REPORT FROM PRODUCT QUALITY GROUP PROVIDING INVESTIGATION RESULTS., COMMENT: BASED ON THE AVAILABLE INFORMATION AND CONSIDERING THE PLAUSIBLE DRUG-EVENT TEMPORAL ASSOCIATION, A CONTRIBUTORY ROLE OF THE SUSPECT PRODUCT ABSORBABLE GELATIN TO THE REPORTED EVENTS ISCHAEMIA AND EMPHYSEMATOUS CYSTITIS CANNOT BE EXCLUDED. IT WAS REPORTED THAT "AFTER TRANSCATHETER ARTERIAL EMBOLIZATION (TAE), BLADDER ISCHEMIA DEVELOPED, REQUIRING LONG-TERM ANTIMICROBIAL THERAPY. PROCEDURAL FACTORS SUCH AS BACKGROUND ILLNESS AND THE PARTICLE SIZE OF THE GELATIN SPONGE USED FOR EMBOLIZATION MAY HAVE CONTRIBUTED TO THE ONSET". CASE WILL BE REASSESSED UPON RECEIPT OF ADDITIONAL INFORMATION. THE IMPACT OF THIS REPORT ON THE BENEFIT/RISK PROFILE OF THE PFIZER PRODUCT IS EVALUATED AS PART OF PFIZER PROCEDURES FOR SAFETY EVALUATION, INCLUDING THE REVIEW AND ANALYSIS OF AGGREGATE DATA FOR ADVERSE EVENTS. ANY SAFETY CONCERN IDENTIFIED AS PART OF THIS REVIEW, AS WELL AS ANY APPROPRIATE ACTION IN RESPONSE, WILL BE PROMPTLY NOTIFIED TO REGULATORY AUTHORITIES, ETHICS COMMITTEES AND INVESTIGATORS, AS APPROPRIATE.

Description of Event or Problem

EVENT VERBATIM [PREFERRED TERM]. TAE WAS PERFORMED USING A GELATIN SPONGE [OFF LABEL USE], TAE WAS PERFORMED USING A GELATIN SPONGE [DEVICE USE ISSUE], BLADDER ISCHEMIA AND EMPHYSEMATOUS CYSTITIS AFTER PERFORMING TAE/DIAGNOSIS OF EMPHYSEMATOUS CYSTITIS DUE TO ISCHEMIA AFTER TAE [ISCHAEMIA], BLADDER ISCHEMIA AND EMPHYSEMATOUS CYSTITIS AFTER PERFORMING TAE/DIAGNOSIS OF EMPHYSEMATOUS CYSTITIS DUE TO ISCHEMIA AFTER TAE [EMPHYSEMATOUS CYSTITIS]. NARRATIVE: THIS IS A LITERATURE REPORT FOR THE FOLLOWING LITERATURE SOURCE(S): "A CASE OF BLADDER ISCHEMIA AND EMPHYSEMATOUS CYSTITIS AFTER PERFORMING TAE FOR PELVIC FRACTURE", THE 53RD ANNUAL MEETING OF THE JAPANESE ASSOCIATION FOR ACUTE MEDICINE, 2025; VOL:53RD, PGS:1878. A FEMALE PATIENT IN HER 80'S RECEIVED ABSORBABLE GELATIN (ABSORBABLE GELATIN), FOR THERAPEUTIC EMBOLISATION. THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDED: "DIABETES MELLITUS" (UNSPECIFIED IF ONGOING); "PELVIC FRACTURE" (UNSPECIFIED IF ONGOING), NOTES: FRACTURES IN THE RIGHT ILIUM AND HIP BONE, RIGHT SACRAL ALA, AND LEFT PUBIC AND ISCHIAL BONES; "COLLIDED WITH A LIGHT AUTOMOBILE WHILE RIDING A MOTORIZED BICYCLE" (UNSPECIFIED IF ONGOING). THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE FOLLOWING INFORMATION WAS REPORTED: OFF LABEL USE (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), DEVICE USE ISSUE (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "RECOVERING" AND ALL DESCRIBED AS "TAE WAS PERFORMED USING A GELATIN SPONGE"; ISCHAEMIA (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), EMPHYSEMATOUS CYSTITIS (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "RECOVERING" AND ALL DESCRIBED AS "BLADDER ISCHEMIA AND EMPHYSEMATOUS CYSTITIS AFTER PERFORMING TAE/DIAGNOSIS OF EMPHYSEMATOUS CYSTITIS DUE TO ISCHEMIA AFTER TAE". THE PATIENT UNDERWENT THE FOLLOWING LABORATORY TESTS AND PROCEDURES: BLOOD PRESSURE MEASUREMENT: 164/94 MMHG; COMPUTERISED TOMOGRAM: SHOWED IMAGES OF CONTRAST AGENT EXTRAVASATION, NOTES: AROUND THE PUBIC FRACTURE; INTRAMURAL EMPHYSEMA OF THE BLADDER, NOTES: AND A RETROPERITONEAL ABSCESS WERE NOTED, LEADING TO A DIAGNOSIS OF EMPHYSEMATOUS CYSTITIS DUE TO ISCHEMIA AFTER TAE; HEART RATE: 88, NOTES: BPM; X-RAY OF PELVIS AND HIP: SHOWED FRACTURES IN THE RIGHT ILIUM AND HIP BONE,, NOTES: RIGHT SACRAL ALA, AND LEFT PUBIC AND ISCHIAL BONES. THE ACTION TAKEN FOR ABSORBABLE GELATIN WAS UNKNOWN. THERAPEUTIC MEASURES WERE TAKEN AS A RESULT OF ISCHAEMIA, EMPHYSEMATOUS CYSTITIS. CLINICAL COURSE: THE PATIENT WITH A HISTORY OF DIABETES MELLITUS. WHILE RIDING A MOTORIZED BICYCLE, SHE COLLIDED WITH A LIGHT AUTOMOBILE AND WAS TRANSPORTED BY AMBULANCE. VITAL SIGNS AT THE INITIAL EXAMINATION WERE BLOOD PRESSURE 164/94 MMHG AND PULSE RATE 88 BPM. PELVIC X-RAY SHOWED FRACTURES IN THE RIGHT ILIUM AND HIP BONE, RIGHT SACRAL ALA, AND LEFT PUBIC AND ISCHIAL BONES, AND CONTRAST-ENHANCED CT SHOWED IMAGES OF CONTRAST AGENT EXTRAVASATION AROUND THE PUBIC FRACTURE. TAE WAS PERFORMED USING A GELATIN SPONGE FROM THE DISTAL SIDE OF THE SUPERIOR GLUTEAL ARTERY BRANCHES OF THE BILATERAL INTERNAL ILIAC ARTERIES. ON DAY 6 OF ILLNESS, THE PATIENT HAD PYREXIA AND BLOOD PRESSURE DECREASED, AND WHEN CONTRAST-ENHANCED CT WAS PERFORMED AGAIN, INTRAMURAL EMPHYSEMA OF THE BLADDER AND A RETROPERITONEAL ABSCESS WERE NOTED, LEADING TO A DIAGNOSIS OF EMPHYSEMATOUS CYSTITIS DUE TO ISCHEMIA AFTER TAE. CONSERVATIVE TREATMENT WITH CFPM WAS STARTED ON THE SAME DAY. THERE WAS NO PROGRESSION TO BLADDER NECROSIS OR PERFORATION, AND THE ABSCESS TENDED TO SHRINK, AND ANTIMICROBIAL AGENTS WERE COMPLETED ON DAY 77 OF ILLNESS. SUBSEQUENTLY, THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR REHABILITATION ON DAY 89 OF ILLNESS. CAUSALITY FOR "TAE WAS PERFORMED USING A GELATIN SPONGE" AND "BLADDER ISCHEMIA AND EMPHYSEMATOUS CYSTITIS AFTER PERFORMING TAE/DIAGNOSIS OF EMPHYSEMATOUS CYSTITIS DUE TO ISCHEMIA AFTER TAE" WAS DETERMINED ASSOCIATED TO ABSORBABLE GELATIN (MALFUNCTION)., COMMENT: BASED ON THE AVAILABLE INFORMATION AND CONSIDERING THE PLAUSIBLE DRUG-EVENT TEMPORAL ASSOCIATION, A CONTRIBUTORY ROLE OF THE SUSPECT PRODUCT ABSORBABLE GELATIN TO THE REPORTED EVENTS ISCHAEMIA AND EMPHYSEMATOUS CYSTITIS CANNOT BE EXCLUDED. IT WAS REPORTED THAT "AFTER TRANSCATHETER ARTERIAL EMBOLIZATION (TAE), BLADDER ISCHEMIA DEVELOPED, REQUIRING LONG-TERM ANTIMICROBIAL THERAPY. PROCEDURAL FACTORS SUCH AS BACKGROUND ILLNESS AND THE PARTICLE SIZE OF THE GELATIN SPONGE USED FOR EMBOLIZATION MAY HAVE CONTRIBUTED TO THE ONSET". CASE WILL BE REASSESSED UPON RECEIPT OF ADDITIONAL INFORMATION. THE IMPACT OF THIS REPORT ON THE BENEFIT/RISK PROFILE OF THE PFIZER PRODUCT IS EVALUATED AS PART OF PFIZER PROCEDURES FOR SAFETY EVALUATION, INCLUDING THE REVIEW AND ANALYSIS OF AGGREGATE DATA FOR ADVERSE EVENTS. ANY SAFETY CONCERN IDENTIFIED AS PART OF THIS REVIEW, AS WELL AS ANY APPROPRIATE ACTION IN RESPONSE, WILL BE PROMPTLY NOTIFIED TO REGULATORY AUTHORITIES, ETHICS COMMITTEES AND INVESTIGATORS, AS APPROPRIATE.