ETHIBOND EXTRA & EXCEL POLYESTER SUTURE
Received Oct 22, 2012
Report 2210968-2012-06694 · MDR key 2799314
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
- Unspecified Infection
- Treatment with medication(s)
Narrative
Description of Event or Problem
IT WAS REPORTED BY THE PATIENT THAT SHE UNDERWENT AN ABDOMINAL WALL PLICATION SURGERY IN (B)(6) 2004 AND SUTURE WAS USED. IN ABOUT (B)(6) 2012, SHE NOTED A SMALL OPENING IN THE MIDDLE OF THE INCISION WITH DISCHARGE. THE OPENING GREW TO THE SIZE OF A QUARTER WITH CLEAR SOMETIMES PUSS LIKE DISCHARGE. THE WOUND CONTINUES TO BE QUARTER SIZE WITH DRAINAGE. THE PATIENT HAS BEEN TREATED WITH ANTIBIOTICS. NO CULTURES HAVE BEEN PERFORMED. THE PRIMARY PHYSICIAN HAS RECOMMENDED THAT THE SUTURE BE REMOVED. 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