POLYGLACTIN 910 SUTURE
Received Aug 10, 2012 · Event occurred Jul 10, 2012
Report 2210968-2012-03855 · MDR key 2691210
Device
Generic name
Suture, Absorble
Manufacturer
Ethicon, IncModel number
NACatalog number
PG130X
Lot number
275905
Product problems
- Break
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2012 AND SUTURE WAS USED. DURING THE PROCEDURE THE SUTURE BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.
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. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2012-03854. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.
Remedial action
- Other