ETHIBOND EXTRA & EXCEL POLYESTER SUTURE

Additional Manufacturer Narrative

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.

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). 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 2210968-2013-04660. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.