InjuryGAS
ETHIBOND EXTRA & EXCEL POLYESTER SUTURE
Received Oct 7, 2010 · Event occurred Jul 8, 2010
Report 2210968-2010-01276 · MDR key 1866889
Device
Generic name
Suture, Non-absorbable
Manufacturer
Ethicon, Inc.Model number
NACatalog number
UNK
Lot number
UNK
Product problems
- Other (for use when an appropriate device code cannot be identified)
Patient
64 YR
- Seroma
- Surgical procedure
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT HAD A DISRUPTION OF A TOTAL KNEE CAPSULAR REPAIR. THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO REPAIR THE FAILED CAPSULAR REPAIR ON (B)(6)2010 AND SUTURE WAS USED. A SEROMA WAS FOUND BY THE SURGEON DURING A FOLLOW UP VISIT AND WAS ASPIRATED. NO ADDITIONAL INFORMATION WAS PROVIDED.
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.