ETHIBOND EXTRA & EXCEL POLYESTER SUTURE
Received Apr 19, 2010 · Event occurred Mar 17, 2010
Report 2210968-2010-00391 · MDR key 1663819
Device
Generic name
Suture, Nonabsorbable
Manufacturer
Ethicon, Inc.Model number
NACatalog number
X32049
Lot number
BL2HDMM0
Product problems
- Break
Patient
UNK
- Nonresorbable materials, unretrieved in body
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2010 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE IN THE PATIENT'S LEFT THIGH (FIXATION OF THE LABIA MAJORA ON THE LEFT THIGH FOR A PROLAPSE). THE SURGEON DECIDED TO LET THE NEEDLE PIECE REMAIN IN-SITU (NATURAL MIGRATION) INSTEAD OF SEARCHING AND CREATING A LARGE SCAR.
Additional Manufacturer Narrative
(B)(4). (B)(4). 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.