MalfunctionGAS
MERSILENE POLYESTER FIBER SUTURE
Received Mar 19, 2014 · Event occurred Sep 23, 2013
Report 2210968-2014-02168 · MDR key 3687742
Device
Product problems
- Break
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UMBILICAL HERNIA REPAIR ON (B)(6) 2013 AND SUTURE WAS USED. WHILE PASSING THE NEEDLE THROUGH THE FASCIA, THE NEEDLE BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.
Additional Manufacturer Narrative
(B)(4). TO DATE, THE DEVICE HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED FOR EVALUATION, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.