SURGIFLO HEMO MATRIX KIT W/THROMBIN

Additional Manufacturer Narrative

PRODUCT COMPLAINT #(B)(4). CONCLUSION OF REVIEW CONDUCTED ON THE BATCH RECORD: A SUBJECT MATTER EXPERT, PRINCIPAL QC SPECIALIST, MICROBIOLOGIST, HAS EVALUATED THE BATCH FILE REVIEW AS SEVERAL DEVIATIONS ARE OBSERVED IN THE BATCH FILE REVIEW. THE PRINCIPAL QC SPECIALIST, MICROBIOLOGIST, CONCLUDE THAT ¿IT IS HIGHLY UNLIKELY THAT THE SURGIFLO WITH BATCH NO. 275890 SHOULD HAVE CAUSED THE REPORTED INFECTION STAPHYLOCOCCUS AUREUS IN THE PATIENT. IT IS CONCLUDED THAT THERE IS NO PRODUCT PROBLEM OR PRODUCT QUALITY ISSUE.¿ THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT A M HEMILAMI PROCEDURE ON (B)(6) 2024 AND ABSORBABLE HEMOSTAT WAS USED. THE PATIENT EXPERIENCED A STAPH AUREUS POST-OPERATIVELY. ADDITIONAL INFORMATION WAS REQUESTED.

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). H6. COMPONENT CODE: G07002 - DEVICE NOT RETURNED. ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: INDICATION SURGIFLO WAS USED? WHICH TYPE OF BLEEDING? LUMBAR MICRODISCECTOMY. MILD OOZING. WAS SURGIFLO LEFT OR REMOVED AFTER HEMOSTASIS WAS ACHIEVED? REMAINED. IS THE CAUSE OF INFECTIONS BEING INVESTIGATED AT THE HOSPITAL SINCE ALSO 2 OTHER SURGERIES RESULTED IN INFECTION (FOR FLOSEAL)? FINDINGS: [(B)(6) 2024 REVISION MICRODISC W/FUSION FLOSEAL & DURASEAL USED. SERRATIA]. [(B)(6) 2024 REV MICRODISC, FLOSEAL USED. STAPH AUREUS]. [(B)(6) 2024 MICRODISC, SURGIFLO#2994. LOT 275885 E.COLI, BREVIBACTERIUM]. [(B)(6) 2024 LUM HEMILAMI- SURGIFLO #2994. LOT 275890. STAPH AUREUS] OR STAFF, AND PT CHARACTERISTICS VARIED. WE'RE ALSO INVESTIGATING A MEDLINE SURGICAL COTTONOID RECALL. HOW MANY DAYS AFTER SURGERY WAS THE INFECTION DISCOVERED? INFECTIONS SYMPTOMS AND ONSET VARIED. AVG 3-4 WEEKS POSTOP. DOES THE PATIENT HAVE A HISTORY OF INFECTIONS? NONE NOTED IN HISTORY. CAN SPECIFIC PATIENT DEMOGRAPHICS INITIALS / ID; AGE OR DATE OF BIRTH; BMI; GENDER; PATIENT PRE-EXISTING MEDICAL CONDITIONS (I.E. ALLERGIES, HISTORY OF REACTIONS), ALL CONCOMITANT MEDICATIONS, PAST MEDICAL HISTORY, ANY TREATMENT REQUIRED FOR EVENTS, DOSE, FREQUENCY, AND THERAPY DATES OF STUDY DRUGS BE PROVIDED? NO. NOT TO THAT EXTENT. THE 4 SSI EVENTS INVOLVED MALE PATIENTS. NO SIGNIFICANT COMORBIDITIES. BMI RANGES: 26 TO 32. ALL WERE READMITTED AND REQUIRED SURGICAL I&D, DRAINS, PICC ABX. WHAT IS THE SURGEON¿S OPINION AS TO THE RELATIONSHIP OF THE PRODUCT TO THE SYMPTOMS? NO COMMENTS RELATING HEMOSTATIC CONTRIBUTING TO SSIS. WAS MEDICAL INTERVENTION INDICATED TO TREAT THE SYMPTOMS? IF SO, WHAT WAS THE MEDICAL INTERVENTION REQUIRED? WHAT IS THE CURRENT CONDITION OF THE PATIENT? SEE ABOVE. ONE PT IN PARTICULAR FROM (B)(6) 2024 HAS BEEN VERY ILL WITH REPEATED READMISSIONS (E.N. (B)(6) 1940. (B)(6)). THE OTHER 3 PTS APPEAR TO BE RESOLVING. IT MENTIONS THAT 4 PATIENT¿S EXPERIENCED SSI¿S. HAVE THE REMAINING 3 SSI¿S BEEN PREVIOUSLY REPORTED TO ETHICON? IS SO, ARE YOU ABLE TO PROVIDE THE COMPLAINT REFERENCES? THEY ARE REFERRING TO 4 INFECTIONS IN TOTAL. THE OTHER 3 OCCURRED WITH OTHER PRODUCTS NOT ETHICON. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.