ETHIBOND EXTRA & EXCEL POLYESTER SUTURE
Received Jun 1, 2012
Report 2210968-2012-01951 · MDR key 2596336
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
- Treatment with medication(s)
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT KNEE SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED ON THE CAPSULE. THE PATIENT EXPERIENCED AN INFLAMMATORY REACTION AND IS BEING TREATED WITH PREDNISOLONE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
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 2210968-2012-01952. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.
Remedial action
- Other