ETHIBOND EXTRA & EXCEL POLYESTER SUTURE
Received Nov 3, 2011 · Event occurred Oct 5, 2011
Report 2210968-2011-01752 · MDR key 2323746
Device
Generic name
Suture, Non-absorbable
Manufacturer
Ethicon, IncModel number
NACatalog number
NI
Lot number
NI
Product problems
- Implant extrusion
Patient
Not reported
- Extrusion
- Surgical procedure
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT AN ULNAR NERVE REPAIR PROCEDURE ON (B)(6) 2006 AND SUTURE WAS USED. ON (B)(6) 2011, THE PATIENT WAS SCRATCHING THE SCAR TISSUE AT THE ELBOW AND WAS ABLE TO PULL A SUTURE THAT WAS KNOTTED OUT OF THE SKIN. THE PATIENT WENT TO THE SURGEON ON (B)(6) 2011 TO HAVE IT REMOVED AND THE SURGEON STATED THE PATIENT WILL NEED TO HAVE SURGERY AGAIN TO HAVE IT REMOVED. RE-OPERATION IS PLANNED FOR (B)(6) 2011.
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.
Remedial action
- Other