ETHIBOND EXTRA & EXCEL POLYESTER SUTURE
Received Feb 3, 2012
Report 2210968-2012-00285 · MDR key 2438690
Device
Generic name
Suture, Non-absorbable
Manufacturer
Ethicon, IncModel number
NACatalog number
NI
Lot number
NI
Product problems
- Other (for use when an appropriate device code cannot be identified)
Patient
65 YR
- Unspecified Infection
- Surgical procedure
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A RECURRENT UMBILICAL HERNIA REPAIR PROCEDURE ON (B)(6) 2011 AND SUTURE WAS USED TO FIXATE THE MESH. ABOUT SIX WEEKS POST OP, THE PATIENT NOTICED DRAINAGE AND HAD AN INFECTION WITH HEAVY GROWTH OF STAPH AUREUS. THE PATIENT UNDERWENT A RE-OPERATION ON (B)(6) 2011. CURRENTLY, THE PATIENT IS DOING GOOD.
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. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2012-00251. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.
Remedial action
- Other