ETHIBOND EXTRA & EXCEL POLYESTER SUTURE
Received Apr 7, 2010
Report 2210968-2010-00331 · MDR key 1655797
Device
Generic name
Suture, Non-absorbable
Manufacturer
Ethicon, Inc.Model number
NACatalog number
UNK
Lot number
UNK
Product problems
- Reaction
Patient
UNK
- Bleeding
- Pain
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT HAD AN UNDISCLOSED VAGINAL SURGERY ON AN UNSPECIFIED DATE, AND SUTURES WERE UTILIZED, FOLLOWING WHICH THE PATIENT EXPERIENCED CONTINUED PAIN AND BLEEDING FOR FIFTEEN MONTHS. AFTER SEVERAL ATTEMPTS TO REMOVE THE SUTURES DURING OFFICE VISITS, THE PATIENT HAD TO UNDERGO A SURGICAL PROCEDURE ON (B) (6) 2010 TO HAVE THE SUTURES REMOVED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.
Additional Manufacturer Narrative
(B) (6): NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.