ETHICON

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. 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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. 1. PLEASE PROVIDE THE FOLLOWING PATIENT DEMOGRAPHIC INFORMATION, IF AVAILABLE: AGE, GENDER, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE? 2. WHAT IS DATE OF INDEX SURGICAL PROCEDURE? 3. WHAT WERE THE DIAGNOSIS AND INDICATION FOR THE INDEX SURGICAL PROCEDURE? 4. PLEASE PROVIDE ANY RELEVANT PATIENT HISTORY: 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. 5. WAS THERE ANY INTRAOPERATIVE CONCURRENT USE OF OTHER PRODUCTS? 6. WHAT IS THE LOT NUMBER? 7. WHAT WAS THE INTENDED USE OF THE SURGICEL? WAS IT USED TO ADDRESS ACTIVE BLEEDING OR USED PROPHYLACTICALLY? 8. WHERE WAS THE SURGICEL USED (ON WHAT TISSUE)? 9. HOW MUCH SURGICEL WAS USED DURING THE PROCEDURE? 10. WAS THE SURGICEL PRODUCT LEFT IN PLACE? WAS THE EXCESS IRRIGATED AND REMOVED? 11. PLEASE DESCRIBE THE PATIENT MANIFESTATIONS OF THE REPORTED INFECTION (LOCATION, SEVERITY, APPEARANCE). 12. PLEASE PROVIDE THE ONSET DATE/TIME OF INFECTION FROM THE INITIAL SURGICAL PROCEDURE. 13. WERE THERE ANY PRE-EXISTING SIGNS/SYMPTOMS OF ACTIVE INFECTION PRIOR TO THIS SURGICAL PROCEDURE? 14. DID THE PATIENT RECEIVE ANY PROPHYLACTIC ANTIBIOTICS PRE-, INTRA- OR POST-OPERATION? 15. WERE CULTURES AND SENSITIVITIES PERFORMED? IF SO, PLEASE PROVIDE THE RESULTS. 16. HOW MUCH AND WHAT TYPE OF DRAINAGE IS PRESENT IN THIS WOUND? (IF APPLICABLE) 17. PLEASE DESCRIBE ANY MEDICAL INTERVENTION PERFORMED INCLUDING MEDICATION NAME AND RESULTS. 18. WERE ANY PRE-OP CLEANSING PROCEDURES CHANGED RECENTLY? IF YES, PLEASE DESCRIBE 19. WHY DOES THE REPORTER BELIEVE THE SURGICEL POWDER IS ASSOCIATED TO THE PATIENT¿S INFECTION? 20. WAS THERE AN ALLEGED DEFICIENCY OF THE SURGICEL THAT CONTRIBUTED TO THE PATIENT¿S POST-OPERATIVE INFECTION? 21. WHAT IS THE PATIENT¿S CURRENT STATUS? 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 C-SECTION PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. FOLLOWING THE PROCEDURE, THE PATIENT DEVELOPED A POSTOPERATIVE INFECTION. THE REPORTER STATED THAT THE INFECTION WAS BELIEVED TO BE ASSOCIATED WITH AN ISSUE INVOLVING THE PRODUCT USED DURING THE PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.