ETHIBOND EXTRA & EXCEL POLYESTER SUTURE
Received Jun 1, 2012
Report 2210968-2012-01950 · MDR key 2596325
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
Not reported
- Inflammation
Narrative
Additional Manufacturer Narrative
(B)(4) - INFLAMMATION OCCURRED. 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 MEDWATCH 2210968-2012-01949. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PATIENT EXPERIENCED AN INFLAMMATORY REACTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Remedial action
- Other