ABSORBABLE GELATIN

Description of Event or Problem

EVENT VERBATIM [PREFERRED TERM] INDICATION: UTERINE ARTERY EMBOLISATION [OFF LABEL USE], INDICATION: UTERINE ARTERY EMBOLISATION [DEVICE USE ISSUE], GELATIN SPONGE STRIPS ALONE DID NOT PROVIDE SUFFICIENT HEMOSTATIC EFFECTS [DRUG INEFFECTIVE] NARRATIVE: THIS IS A LITERATURE REPORT FROM PRODUCT QUALITY GROUP FOR THE FOLLOWING LITERATURE SOURCE(S): "A CASE OF PLACENTA ACCRETA IN PREGNANCY AFTER UTERINE ARTERY EMBOLISATION FOR OBSTETRIC CRISIS HAEMORRHAGE", THE TOKAI JOURNAL OF OBSTETRICS AND GYNECOLOGY, 2025; VOL:61, PGS:183-188. A 36-YEAR-OLD FEMALE PATIENT RECEIVED ABSORBABLE GELATIN (ABSORBABLE GELATIN), FOR UTERINE ARTERY EMBOLISATION. THE PATIENT'S RELEVANT MEDICAL HISTORY AND 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 "RECOVERED" AND ALL DESCRIBED AS "INDICATION: UTERINE ARTERY EMBOLISATION"; DRUG INEFFECTIVE (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "RECOVERED", DESCRIBED AS "GELATIN SPONGE STRIPS ALONE DID NOT PROVIDE SUFFICIENT HEMOSTATIC EFFECTS". THE PATIENT UNDERWENT THE FOLLOWING LABORATORY TESTS AND PROCEDURES: BLOOD FIBRINOGEN: 96 MG/DL, NOTES: LOW, BEFORE UAE; HAEMOGLOBIN: 3.2 G/DL, NOTES: BEFORE UAE. THE ACTION TAKEN FOR ABSORBABLE GELATIN WAS UNKNOWN. THERAPEUTIC MEASURES WERE TAKEN AS A RESULT OF DRUG INEFFECTIVE. CLINICAL COURSE: AMONG THEM, NBCA WAS USED IN ONE CASE OF ATONIC HAEMORRHAGE OTHER THAN THIS CASE (TABLE 2, CASE 5). IN THIS CASE, FIBRINOGEN IMMEDIATELY BEFORE UAE WAS ALSO LOW AT 96 MG/DL, AND GELATIN SPONGE STRIPS ALONE DID NOT PROVIDE SUFFICIENT HEMOSTATIC EFFECTS. THUS, NBCA WAS ADDED, RESULTING IN HEMOSTASIS. THERE WERE NO COMPLICATIONS SUCH AS PLACENTA ACCRETA IN PREGNANCY AFTER UAE. PRODUCT QUALITY GROUP PROVIDED INVESTIGATIONAL RESULTS ON (B)(6) 2025 FOR ABSORBABLE GELATIN: INVESTIGATION SUMMARY AND CONCLUSION: NO FURTHER MANUFACTURING INVESTIGATION IS REQUIRED AS NO VALID LOT NUMBER OR RETURNED SAMPLE IS AVAILABLE. THIS COMPLAINT WILL CONTINUE TO BE TRENDED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS COMPLAINT WILL BE REOPENED. CAUSALITY FOR "INDICATION: UTERINE ARTERY EMBOLISATION" AND "GELATIN SPONGE STRIPS ALONE DID NOT PROVIDE SUFFICIENT HEMOSTATIC EFFECTS" WAS DETERMINED ASSOCIATED TO ABSORBABLE GELATIN (MALFUNCTION). FOLLOWUP (13MAY2025): THIS IS A SPONTANEOUS FOLLOW-UP REPORT OBTAINED FROM PRODUCT QUALITY GROUP. INVESTIGATION RESULT WAS REPORTED., COMMENT: BASED ON THE INFORMATION CURRENTLY AVAILABLE, A CAUSAL ASSOCIATION BETWEEN THE REPORTED EVENT DRUG INEFFECTIVE AND ABSORBABLE GELATIN CANNOT BE EXCLUDED.

Description of Event or Problem

EVENT VERBATIM [PREFERRED TERM] INDICATION: UTERINE ARTERY EMBOLISATION [OFF LABEL USE], INDICATION: UTERINE ARTERY EMBOLISATION [DEVICE USE ISSUE], GELATIN SPONGE STRIPS ALONE DID NOT PROVIDE SUFFICIENT HEMOSTATIC EFFECTS [DRUG INEFFECTIVE]. NARRATIVE: THIS IS A LITERATURE REPORT FROM PRODUCT QUALITY GROUP FOR THE FOLLOWING LITERATURE SOURCE(S): "A CASE OF PLACENTA ACCRETA IN PREGNANCY AFTER UTERINE ARTERY EMBOLISATION FOR OBSTETRIC CRISIS HAEMORRHAGE", THE TOKAI JOURNAL OF OBSTETRICS AND GYNECOLOGY, 2025; VOL:61, PGS:183-188. A 36-YEAR-OLD FEMALE PATIENT RECEIVED ABSORBABLE GELATIN (ABSORBABLE GELATIN), FOR UTERINE ARTERY EMBOLISATION. THE PATIENT'S RELEVANT MEDICAL HISTORY AND 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 "RECOVERED" AND ALL DESCRIBED AS "INDICATION: UTERINE ARTERY EMBOLISATION"; DRUG INEFFECTIVE (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "RECOVERED", DESCRIBED AS "GELATIN SPONGE STRIPS ALONE DID NOT PROVIDE SUFFICIENT HEMOSTATIC EFFECTS". THE PATIENT UNDERWENT THE FOLLOWING LABORATORY TESTS AND PROCEDURES: BLOOD FIBRINOGEN: 96 MG/DL, NOTES: LOW, BEFORE UAE; HAEMOGLOBIN: 3.2 G/DL, NOTES: BEFORE UAE. THE ACTION TAKEN FOR ABSORBABLE GELATIN WAS UNKNOWN. THERAPEUTIC MEASURES WERE TAKEN AS A RESULT OF DRUG INEFFECTIVE. CLINICAL COURSE: AMONG THEM, NBCA WAS USED IN ONE CASE OF ATONIC HAEMORRHAGE OTHER THAN THIS CASE (TABLE 2, CASE 5). IN THIS CASE, FIBRINOGEN IMMEDIATELY BEFORE UAE WAS ALSO LOW AT 96 MG/DL, AND GELATIN SPONGE STRIPS ALONE DID NOT PROVIDE SUFFICIENT HEMOSTATIC EFFECTS. THUS, NBCA WAS ADDED, RESULTING IN HEMOSTASIS. THERE WERE NO COMPLICATIONS SUCH AS PLACENTA ACCRETA IN PREGNANCY AFTER UAE. PRODUCT QUALITY GROUP PROVIDED INVESTIGATIONAL RESULTS ON (B)(6) 2025 FOR ABSORBABLE GELATIN: INVESTIGATION SUMMARY AND CONCLUSION: NO FURTHER MANUFACTURING INVESTIGATION IS REQUIRED AS NO VALID LOT NUMBER OR RETURNED SAMPLE IS AVAILABLE. THIS COMPLAINT WILL CONTINUE TO BE TRENDED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS COMPLAINT WILL BE REOPENED. CAUSALITY FOR "INDICATION: UTERINE ARTERY EMBOLISATION" AND "GELATIN SPONGE STRIPS ALONE DID NOT PROVIDE SUFFICIENT HEMOSTATIC EFFECTS" WAS DETERMINED ASSOCIATED TO ABSORBABLE GELATIN (MALFUNCTION). FOLLOWUP (13MAY2025): THIS IS A SPONTANEOUS FOLLOW-UP REPORT OBTAINED FROM PRODUCT QUALITY GROUP. INVESTIGATION RESULT WAS REPORTED. FOLLOW-UP (10JUN2025): THIS IS A FOLLOW-UP REPORT FROM PRODUCT QUALITY GROUP PROVIDING UPDATED IMDRF/FDA CODES., COMMENT: BASED ON THE INFORMATION CURRENTLY AVAILABLE, A CAUSAL ASSOCIATION BETWEEN THE REPORTED EVENT DRUG INEFFECTIVE AND ABSORBABLE GELATIN CANNOT BE EXCLUDED.

Description of Event or Problem

EVENT [PREFERRED TERM] INDICATION: UTERINE ARTERY EMBOLISATION [OFF LABEL USE], INDICATION: UTERINE ARTERY EMBOLISATION [DEVICE USE ISSUE], GELATIN SPONGE STRIPS ALONE DID NOT PROVIDE SUFFICIENT HEMOSTATIC EFFECTS [DRUG INEFFECTIVE]. NARRATIVE: THIS IS A LITERATURE REPORT FOR THE FOLLOWING LITERATURE SOURCE(S): "A CASE OF PLACENTA ACCRETA IN PREGNANCY AFTER UTERINE ARTERY EMBOLISATION FOR OBSTETRIC CRISIS HAEMORRHAGE", THE TOKAI JOURNAL OF OBSTETRICS AND GYNECOLOGY, 2025; VOL:61, PGS:183-188. A 36-YEAR-OLD FEMALE PATIENT RECEIVED ABSORBABLE GELATIN (ABSORBABLE GELATIN), FOR UTERINE ARTERY EMBOLISATION. THE PATIENT'S RELEVANT MEDICAL HISTORY AND 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 "RECOVERED" AND ALL DESCRIBED AS "INDICATION: UTERINE ARTERY EMBOLISATION"; DRUG INEFFECTIVE (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "RECOVERED", DESCRIBED AS "GELATIN SPONGE STRIPS ALONE DID NOT PROVIDE SUFFICIENT HEMOSTATIC EFFECTS". THE PATIENT UNDERWENT THE FOLLOWING LABORATORY TESTS AND PROCEDURES: BLOOD FIBRINOGEN: 96 MG/DL, NOTES: LOW, BEFORE UAE; HAEMOGLOBIN: 3.2 G/DL, NOTES: BEFORE UAE. THE ACTION TAKEN FOR ABSORBABLE GELATIN WAS UNKNOWN. THERAPEUTIC MEASURES WERE TAKEN AS A RESULT OF DRUG INEFFECTIVE. CLINICAL COURSE: AMONG THEM, NBCA WAS USED IN ONE CASE OF ATONIC HAEMORRHAGE OTHER THAN THIS CASE (TABLE 2, CASE 5). IN THIS CASE, FIBRINOGEN IMMEDIATELY BEFORE UAE WAS ALSO LOW AT 96 MG/DL, AND GELATIN SPONGE STRIPS ALONE DID NOT PROVIDE SUFFICIENT HEMOSTATIC EFFECTS. THUS, NBCA WAS ADDED, RESULTING IN HEMOSTASIS. THERE WERE NO COMPLICATIONS SUCH AS PLACENTA ACCRETA IN PREGNANCY AFTER UAE. CAUSALITY FOR "INDICATION: UTERINE ARTERY EMBOLISATION" AND "GELATIN SPONGE STRIPS ALONE DID NOT PROVIDE SUFFICIENT HEMOSTATIC EFFECTS" WAS DETERMINED ASSOCIATED TO ABSORBABLE GELATIN (MALFUNCTION)., COMMENT: BASED ON THE INFORMATION CURRENTLY AVAILABLE, A CAUSAL ASSOCIATION BETWEEN THE REPORTED EVENT DRUG INEFFECTIVE ANDABSORBABLE GELATIN CANNOT BE EXCLUDED.

Description of Event or Problem

EVENT VERBATIM [PREFERRED TERM] INDICATION: UTERINE ARTERY EMBOLISATION [OFF LABEL USE], INDICATION: UTERINE ARTERY EMBOLISATION [DEVICE USE ISSUE], GELATIN SPONGE STRIPS ALONE DID NOT PROVIDE SUFFICIENT HEMOSTATIC EFFECTS [DRUG INEFFECTIVE] NARRATIVE: THIS IS A LITERATURE REPORT FROM PRODUCT QUALITY GROUP FOR THE FOLLOWING LITERATURE SOURCE(S): "A CASE OF PLACENTA ACCRETA IN PREGNANCY AFTER UTERINE ARTERY EMBOLISATION FOR OBSTETRIC CRISIS HAEMORRHAGE", THE TOKAI JOURNAL OF OBSTETRICS AND GYNECOLOGY, 2025; VOL:61, PGS:183-188. A 36-YEAR-OLD FEMALE PATIENT RECEIVED ABSORBABLE GELATIN (ABSORBABLE GELATIN), FOR UTERINE ARTERY EMBOLISATION. THE PATIENT'S RELEVANT MEDICAL HISTORY AND 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 "RECOVERED" AND ALL DESCRIBED AS "INDICATION: UTERINE ARTERY EMBOLISATION"; DRUG INEFFECTIVE (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "RECOVERED", DESCRIBED AS "GELATIN SPONGE STRIPS ALONE DID NOT PROVIDE SUFFICIENT HEMOSTATIC EFFECTS". THE PATIENT UNDERWENT THE FOLLOWING LABORATORY TESTS AND PROCEDURES: BLOOD FIBRINOGEN: 96 MG/DL, NOTES: LOW, BEFORE UAE; HAEMOGLOBIN: 3.2 G/DL, NOTES: BEFORE UAE. THE ACTION TAKEN FOR ABSORBABLE GELATIN WAS UNKNOWN. THERAPEUTIC MEASURES WERE TAKEN AS A RESULT OF DRUG INEFFECTIVE. CLINICAL COURSE: AMONG THEM, NBCA WAS USED IN ONE CASE OF ATONIC HAEMORRHAGE OTHER THAN THIS CASE. IN THIS CASE, FIBRINOGEN IMMEDIATELY BEFORE UAE WAS ALSO LOW AT 96 MG/DL, AND GELATIN SPONGE STRIPS ALONE DID NOT PROVIDE SUFFICIENT HEMOSTATIC EFFECTS. THUS, NBCA WAS ADDED, RESULTING IN HEMOSTASIS. THERE WERE NO COMPLICATIONS SUCH AS PLACENTA ACCRETA IN PREGNANCY AFTER UAE. PRODUCT QUALITY GROUP PROVIDED INVESTIGATIONAL RESULTS ON 13MAY2025 FOR ABSORBABLE GELATIN: INVESTIGATION SUMMARY AND CONCLUSION: NO FURTHER MANUFACTURING INVESTIGATION IS REQUIRED AS NO VALID LOT NUMBER OR RETURNED SAMPLE IS AVAILABLE. THIS COMPLAINT WILL CONTINUE TO BE TRENDED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS COMPLAINT WILL BE REOPENED. CAUSALITY FOR "INDICATION: UTERINE ARTERY EMBOLISATION" AND "GELATIN SPONGE STRIPS ALONE DID NOT PROVIDE SUFFICIENT HEMOSTATIC EFFECTS" WAS DETERMINED ASSOCIATED TO ABSORBABLE GELATIN (MALFUNCTION). FOLLOWUP (13MAY2025): THIS IS A SPONTANEOUS FOLLOW-UP REPORT OBTAINED FROM PRODUCT QUALITY GROUP. INVESTIGATION RESULT WAS REPORTED. FOLLOW-UP (10JUN2025): THIS IS A FOLLOW-UP REPORT FROM PRODUCT QUALITY GROUP PROVIDING UPDATED IMDRF/FDA CODES. FOLLOW-UP (01NOV2025): THIS IS A FOLLOW-UP REPORT FROM PRODUCT QUALITY GROUP PROVIDING INVESTIGATION RESULT. ADDITIONAL INFORMATION: INVESTIGATION SUMMARY AND CONCLUSION: 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., COMMENT: BASED ON THE INFORMATION CURRENTLY AVAILABLE, A CAUSAL ASSOCIATION BETWEEN THE REPORTED EVENT DRUG INEFFECTIVE AND ABSORBABLE GELATIN CANNOT BE EXCLUDED.