InjuryGAS
ETHIBOND EXTRA & EXCEL POLYESTER SUTURE
Received Aug 14, 2012
Report 2210968-2012-03951 · MDR key 2695323
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
Not reported
- Wound Dehiscence
- Surgical procedure
Narrative
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 WOUND DEHISCENCE THAT REQUIRED A REOPERATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
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.
Remedial action
- Other