FDA Adverse Event
Injury
Summary report: N
OCU-GUARD
MDR report key: 236195
·
Received August 16, 1999
Report
- Report Number
- 2183620-1999-00019
- Event Type
- Injury
- Date Received
- August 16, 1999
- Date of Event
- February 10, 1999
- Manufacturer
- BIO-VASCULAR, INC.
- Product Code
- MTZ
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OCU-GUARD Implant | ORBITAL IMPLANT WRAP | MTZ | BIO-VASCULAR, INC. | * | OGS-97J28-075 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR | Required Intervention |