ETHIBOND EXTRA & EXCEL POLYESTER SUTURE
Received Apr 9, 2010 · Event occurred Mar 6, 2010
Report 2210968-2010-00330 · MDR key 1657559
Device
Generic name
Suture, Non-absorbable
Manufacturer
Ethicon, Inc.Model number
NACatalog number
XZW6923
Lot number
AHR671
Product problems
- Other (for use when an appropriate device code cannot be identified)
Patient
UNK
- Wound Dehiscence
- Surgical procedure
Narrative
Additional Manufacturer Narrative
(B) (4). (B) (4) - WOUND DEHISCENCE. THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED HAS BEEN RECEIVED, HOWEVER, THE PRODUCT EVAL IS NOT YET COMPLETE. ANY FURTHER INFO DERIVED FROM THE EVAL WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. IN ADDITION, A REVIEW OF THE BATCH MFG RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.
Description of Event or Problem
IT WAS REPORTED THAT A PT UNDERWENT A RHINOPLASTY PROCEDURE ON AN UNK DATE. THE WOUND "BROKE DOWN" A FEW DAYS LATER AND THE PT HAD TO GO BACK TO OPERATING THEATRE FOR RE-SUTURING. ADDITIONAL INFO HAS BEEN REQUESTED.