ETHIBOND EXTRA & EXCEL POLYESTER SUTURE
Received Jan 21, 2011
Report 2210968-2011-00064 · MDR key 1974329
Device
Generic name
Suture, Nonabsorbable
Manufacturer
Ethicon, Inc.Model number
NACatalog number
X31026
Lot number
CC2BBCM0
Product problems
- Break
Patient
UNK
- Migration
Narrative
Additional Manufacturer Narrative
(B)(4). CONCLUSION: 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. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2011-00065. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A UROLOGY LAPAROSCOPIC PROMONTOFIXATION PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED TO FIX THE TAPE TO THE PRESACRAL LIGAMENT. POST-OPERATIVELY THE SUTURE BROKE AND THE TAPE PLACED WITH THE SUTURES HAVE BEEN "EJECTED THROUGH NATURAL ROUTES". ANOTHER OPERATION IS SCHEDULED TO REPLACE THE TAPE.