InjuryMTZ
OCU-GUARD
Received Aug 16, 1999
Report 2183620-1999-00018 · MDR key 236223
Device
Generic name
Orbital Wrap
Manufacturer
Bio-vascular, Inc.Model number
*Catalog number
*
Lot number
OGS-97J28-070
Product problems
- Unknown (for use when the device problem is not known)
Patient
79 YR
- Organ Dehiscence
Narrative
Description of Event or Problem
PATIENT UNDERWENT ENUCLEATION SURGERY FOR REMOVAL OF A BLIND, PAINFUL EYE. OCU-GUARD (FLAT CONFIGURATION) WAS USED AS THE ORBITAL IMPLANT WRAP. PATIENT LATER PRESENTED WITH DEHISCENCE OVER THE IMPLANT (DATE UNKNOWN). UNABLE TO FIT FOR PROSTHESIS. NO INTERVENTION AT THAT TIME, OBSERVATION ONLY. PATIENT NOW LOST TO FOLLOW-UP.