MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1999-08-27 for OCU-GUARD NI * manufactured by Bio-vascular.
[15709211]
Ocu-guard implanted in 1998 (indication unk). Over the course of the year, cellulitis, drainage and exposure occurred. Infection set in repeatedly and the ocu-guard was explanted (date unk). No further information available at this time; requested from the surgeon five times.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183620-1999-00023 |
| MDR Report Key | 238256 |
| Report Source | 05 |
| Date Received | 1999-08-27 |
| Date of Report | 1999-08-27 |
| Date Mfgr Received | 1999-06-25 |
| Date Added to Maude | 1999-09-03 |
| 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 | 1999-08-27 |
| Model Number | NI |
| Catalog Number | * |
| Lot Number | NI |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | I |
| Device Sequence No | 1 |
| Device Event Key | 230890 |
| Manufacturer | BIO-VASCULAR |
| Manufacturer Address | 2575 UNIVERSITY AVE. ST. PAUL MN 55114 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 1999-08-27 |