ETHIBOND EXTRA AND EXCEL POLYSTER SUTURE
Received Apr 4, 2012
Report 2210968-2012-00941 · MDR key 2523474
Device
Generic name
Suture, Non-absorbable
Manufacturer
Ethicon, Inc.Model number
NACatalog number
NI
Lot number
NI
Product problems
- Other (for use when an appropriate device code cannot be identified)
Patient
NI
- Unspecified Infection
- Pain
- Surgical procedure
- Drainage
Narrative
Additional Manufacturer Narrative
(B)(4). INFECTION OCCURRED. CONCLUSION: 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 MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2012-00498. THE SAME PT IS REPRESENTED IN EACH MEDWATCH.
Description of Event or Problem
IT WAS REPORTED THAT A PT UNDERWENT AN OPEN VENTRAL HERNIA REPAIR PROCEDURE ON (B)(6) 2012 AND SUTURE WAS USED TO FIXATE THE MESH. ONE MONTH FOLLOWING THE PROCEDURE, THE PT PRESENTED WITH SYMPTOMS OF PAIN AND DRAINAGE AND HAD AN INFECTION. THE PT UNDERWENT REOPERATION ON (B)(6) 2012.