InjuryGAS
MERSILENE POLYESTER FIBER SUTURE
Received Mar 10, 2014
Report 2210968-2014-02030 · MDR key 3670662
Device
Generic name
Suture Non Absorbable
Manufacturer
Ethicon Inc.Model number
UNKCatalog number
UNK
Lot number
UNK
Product problems
- Other (for use when an appropriate device code cannot be identified)
Patient
Not reported
- Nerve Damage
- Surgical procedure
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 BY THE PATIENT THAT SHE UNDERWENT A PROCEDURE ON AND UNKNOWN DATE AND SUTURE WAS USED. SHE STATED THAT POST OPERATIVELY SHE DEVELOPED NERVE DAMAGE CAUSING FACIAL DROOPING. THE PATIENT UNDERWENT AN OPEN HEAD AND NECK RE-EXPLORATION, IN WHICH THE SURGEON REMOVED THE SUTURE PREVIOUSLY IMPLANTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.