InjuryMTZ
OCU-GUARD
Received Aug 16, 1999 · Event occurred Feb 10, 1999
Report 2183620-1999-00019 · MDR key 236195
Device
Generic name
Orbital Implant Wrap
Manufacturer
Bio-vascular, Inc.Model number
*Catalog number
*
Lot number
OGS-97J28-075
Product problems
- Device remains implanted
Patient
29 YR
- Wound Dehiscence
- Surgical procedure, repeated
- Surgical procedure
- Surgical procedure, additional
Narrative
Description of Event or Problem
PATIENT RECEIVED A NEW ORBITAL IMPLANT WRAPPED WITH OCU-GUARD TO REPLACE A PREVIOUSLY-INSERTED, TOO-SMALL ORBITAL IMPLANT, FOLLOWING PREVIOUS ENUCLEATION SURGERY. THE DATE OF THE OCU-GUARD IMPLANT WAS 1999. ON 02/10/1999 AND 01/18/1999, THE PATIENT PRESENTED WITH WOUND DEHISCENCE WHICH WAS REPAIRED BY PRIMARY CLOSURE, AND ON 05/05/1990 FOR A MUCOUS MEMBRANE GRAFT. THE DEHISCENCES INVOLVED BOTH THE CONJUCTIVA AND TENON'S CAPSULE ("LAYER"). PATIENT IS STILL UNABLE TO WEAR A PERMANENT PROSTHESIS.