ETHIBOND EXTRA & EXCEL POLYESTER SUTURE
Received Oct 27, 2009 · Event occurred Jul 1, 2009
Report 2210968-2009-01217 · MDR key 1519949
Device
Generic name
Suture, Non-absorbable
Manufacturer
Ethicon, Inc.Model number
NACatalog number
EH7715LG
Lot number
AE2DJZM0
Product problems
- Other (for use when an appropriate device code cannot be identified)
Patient
UNK
- Surgical procedure
- Post Operative Wound Infection
Narrative
Description of Event or Problem
INTERNATIONAL CUSTOMER REPORTED THAT A PT UNDERWENT A HEART VALVE REPLACEMENT IN 2009 AND SUBSEQUENTLY PRESENTED WITH AN INFECTION THE FOLLOWING MONTH. THE PT WAS RETURNED TO SURGERY FOR DRAINAGE. THE EVENT DID NOT RESOLVE SO THE PT WAS RETURNED TO SURGERY FOR EXPLANT AND REPLACEMENT OF THE HEART VALVE THREE MONTHS LATER. THE PT IS REPORTED AS STABLE.
Additional Manufacturer Narrative
DATE SENT TO FDA: 10/23/2009. INFECTION OCCURRED - CONCLUSION: A REVIEW OF THE BATCH MFG RECORDS WAS CONDUCTED. THIS REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES AND THE BATCH MET ALL STERILIZATION RELEASE CRITERIA. NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADD'L INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. THIS IS ONE OF TWO MEDWATCH REPORTS BEING SUBMITTED AS TWO SEPARATE DEVICES WERE USED. SEE 2210968-2009-01216 FOR THE OTHER MEDWATCH. THE SAME PT REPRESENTED IN EACH MEDWATCH.