MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1999-08-16 for OCU-GUARD * manufactured by Bio-vascular, Inc..
[136012]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183620-1999-00019 |
| MDR Report Key | 236195 |
| Report Source | 05 |
| Date Received | 1999-08-16 |
| Date of Event | 1999-02-10 |
| Date Mfgr Received | 1999-08-03 |
| Device Manufacturer Date | 1997-10-01 |
| Date Added to Maude | 1999-08-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OCU-GUARD |
| Generic Name | ORBITAL IMPLANT WRAP |
| Product Code | MTZ |
| Date Received | 1999-08-16 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | OGS-97J28-075 |
| ID Number | * |
| Device Expiration Date | 2002-10-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 228903 |
| Manufacturer | BIO-VASCULAR, INC. |
| Manufacturer Address | 2575 UNIVERSITY AVE. #180 ST. PAUL MN 55114 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1999-08-16 |