ETHIBOND EXTRA & EXCEL POLYESTER SUTURE
Received Apr 29, 2013
Report 2210968-2013-04651 · MDR key 3082996
Device
Generic name
Suture, Non-absorbable
Manufacturer
Ethicon, Inc.Model number
NACatalog number
10X42
Lot number
NI
Product problems
- Implant extrusion
Patient
Not reported
- Extrusion
- Granuloma
- Surgical procedure
Narrative
Additional Manufacturer Narrative
(B)(4). CONCLUSION: 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 TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2013-04650. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.
Description of Event or Problem
IT WAS REPORTED THAT A PEDIATRIC PATIENT UNDERWENT AN UMBILICAL HERNIA REPAIR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. APPROXIMATELY 4 TO 6 WEEKS POST-OPERATIVELY, THE PATIENT EXPERIENCED SPITTING OF THE SUTURE AT THE UMBILICUS . THE PATIENT UNDERWENT A SECOND SURGERY TO REMOVE THE SUTURES. DURING THE PROCEDURE, GRANULOMA FORMATION AND TISSUE BREAKDOWN WERE FOUND. ADDITIONAL INFORMATION REQUESTED.
Remedial action
- Other