InjuryGAS
ETHIBOND EXTRA & EXCEL POLYESTER SUTURE
Received Jan 26, 2012
Report 2210968-2012-00206 · MDR key 2429326
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
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT AN ACHILLES TENDON REPAIR PROCEDURE ON AN UNKNOWN DATE MONTHS AGO AND SUTURE WAS USED. THE PATIENT EXPERIENCED INCREASED INFLAMMATION AT THE SITE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Additional Manufacturer Narrative
(B)(4). INFLAMMATION - LABELED. 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