ETHIBOND EXTRA & EXCEL POLYESTER SUTURE
Received Sep 23, 2010 · Event occurred Aug 23, 2010
Report 2210968-2010-01186 · MDR key 1851282
Device
Generic name
Suture, Nonabsorbable
Manufacturer
Ethicon, Inc.Model number
NACatalog number
X425H
Lot number
AHR669
Product problems
- Break
Patient
UNK
- 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) 2010 AND SUTURE WAS USED. THE NEEDLE SNAPPED DURING THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.
Additional Manufacturer Narrative
(B)(4). CONCLUSIONS: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. 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 2210968-2010-01185. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.