ETHIBOND EXTRA & EXCEL POLYESTER SUTURE

Description of Event or Problem

IT WAS REPORTED THAT A PEDIATRIC PATIENT UNDERWENT AN UMBILICAL HERNIA REPAIR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. APPROXIMATELY 4 TO 6 WEEKS POST-OPERATIVELY, THE PATIENT EXPERIENCED SPITTING OF THE SUTURE AT THE UMBILICUS . THE PATIENT UNDERWENT A SECOND SURGERY TO REMOVE THE SUTURES. DURING THE PROCEDURE, GRANULOMA FORMATION AND TISSUE BREAKDOWN WERE FOUND. ADDITIONAL INFORMATION REQUESTED.

Additional Manufacturer Narrative

(B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE ACCOUNT REPORTS THE FOLLOWING POSSIBLE BATCH NUMBER: BATCH DPP466 MFG DATE: 12/01/2011, EXP DATE: 07/31/2016. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2013-04658. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

Additional Manufacturer Narrative

(B)(4). IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS FOR THE POSSIBLE BATCH NUMBERS WAS CONDUCTED AND THE BATCHES MET ALL FINISHED GOODS RELEASE CRITERIA.