InjuryGAS
ETHIBOND EXTRA & EXCEL POLYESTER SUTURE
Received Jul 11, 2012
Report 2210968-2012-02699 · MDR key 2650213
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
- Hernia
- Surgical procedure
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A FEMORAL HERNIA REPAIR PROCEDURE ON (B)(6) 2010 AND SUTURE WAS USED. THE PATIENT DEVELOPED A RECURRENT HERNIA. DURING THE REPAIR PROCEDURE ON (B)(6) 2011, IT WAS NOTED THAT NONE OF THE SUTURE WAS PRESENT AT THE SITE OF THE ORIGINAL REPAIR. ADDITIONAL INFORMATION TO BE 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