InjuryGAS
ETHIBOND EXTRA & EXCEL POLYESTER SUTURE
Received Apr 27, 2011
Report 2210968-2011-00515 · MDR key 2070899
Device
Generic name
Suture, Non-absorbable
Manufacturer
Ethicon, Inc.Model number
NACatalog number
PXX41
Lot number
NI
Product problems
- Other (for use when an appropriate device code cannot be identified)
Patient
Not reported
- Surgical procedure
- Post Operative Wound Infection
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A VALVE REPLACEMENT PROCEDURE ON (B)(6) 2010 AND SUTURE WAS USED. THE PATIENT EXPERIENCED A POST-OPERATIVE INFECTION OF THE VALVE AT THE SITE WHERE THE SUTURE ATTACHED TO THE VALVE. THE INFECTION REQUIRED A REPEAT SURGERY AND REPLACEMENT OF THE VALVE AND EXTENDED HOSPITAL STAY.
Additional Manufacturer Narrative
DATE SENT TO THE FDA: 04/27/2011. (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