ETHIBOND EXTRA & EXCEL POLYESTER SUTURE
Received May 1, 2012
Report 2210968-2012-01353 · MDR key 2555545
Device
Generic name
Suture, Non-absorbable
Manufacturer
Ethicon, IncModel number
NACatalog number
NI
Lot number
NI
Product problems
- Material Erosion
Patient
Not reported
- Erosion
- Pain
- Surgical procedure
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE TO TREAT STRESS URINARY INCONTINENCE ON (B)(6) 2010 AND SUTURE WAS USED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.
Additional Manufacturer Narrative
(B)(4). THIS IS ONE OF FOUR MEDWATCHES BEING SUBMITTED AS FOUR DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2012-01351, 2210968-2012-01352 AND 2210968-2012-04375. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.
Additional Manufacturer Narrative
(B)(4): NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.THIS IS ONE OF THREE MEDWATCHES BEING SUBMITTED AS THREE DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2012-01351 AND MEDWATCH 2210968-2012-01352. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.
Remedial action
- Other