ETHILON NYLON SUTURE
Received Nov 24, 2010 · Event occurred Oct 26, 2010
Report 2210968-2010-01604 · MDR key 1910363
Device
Generic name
Suture, Nonabsorbable
Manufacturer
Ethicon, Inc.Model number
NACatalog number
W741
Lot number
VE803
Product problems
- Break
Patient
UNK
- Wound Dehiscence
Narrative
Additional Manufacturer Narrative
(B)(4). CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFO DERIVED FROM THE EVAL WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.
Description of Event or Problem
IT WAS REPORTED THAT A PT UNDERWENT A CESAREAN SECTION PROCEDURE ON (B)(6) 2010 AND SUTURE WAS USED. THE PT RETURNED ON (B)(6) 2010 WITH A BURST ABDOMEN. UPON INVESTIGATION, PART OF THE SUTURE WAS ONLY FOUND ON BOTH ENDS OF THE INCISION. THE MID SECTION SUTURE WAS NOT FOUND. THE SURGEON OPINES THAT THE SUTURE WAS THE CAUSE. ADDITIONAL INFO WAS REQUESTED.