InjuryKGS
RETENTION SUTURE BRIDGE
Received Jul 2, 2014 · Event occurred Mar 12, 2014
Report 2210968-2014-08603 · MDR key 3909435
Device
Generic name
Suture Accessories
Manufacturer
Ethicon Inc.Model number
UNKCatalog number
RSB5
Lot number
UNK
Product problems
- Other (for use when an appropriate device code cannot be identified)
Patient
Not reported
- Wound Dehiscence
- Necrosis
Narrative
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.
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A SURGICAL PROCEDURE ON AN UNKNOWN DATE AND A SUTURE RETENTION BRIDGE WAS USED. THE PATIENT EXPERIENCED A SKIN NECROSIS ON THE SAME DAY AND THE INCISION WASN'T PROPERLY CLOSED. THE INCISION REOPENED WITH THE BRIDGE IN PLACE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.