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..
[15708345]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183620-1999-00018 |
| MDR Report Key | 236223 |
| Report Source | 05 |
| Date Received | 1999-08-16 |
| Date of Report | 1999-08-13 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OCU-GUARD |
| Generic Name | ORBITAL WRAP |
| Product Code | MTZ |
| Date Received | 1999-08-16 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | OGS-97J28-070 |
| 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 | 228926 |
| Manufacturer | BIO-VASCULAR, INC. |
| Manufacturer Address | 2575 UNIVERSITY AVE. ST. PAUL MN 55114 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1999-08-16 |