MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1999-04-28 for OCU-GUARD UNK manufactured by Bio-vascular, Inc..
[129031]
The surgeon reported that on 01/11/1999, he performed an enucleation procedure using ocu-guard as the hydroxyapetite orbital implant wrap to treat the pt for a blind, painful eye. Following this procedure, the pt presented with exposure of the orbital implant wrap accompanied by excessive drainage. The surgeon then removed the hydroxyapetite implant and replaced it with a silicone sphere. Subsequently, the pt presented with extrusion of the implant and the surgeon also removed the ocu-guard orbital implant wrap. The surgeon stated that the pt experienced a "probable allergic reaction". The pt is healing from the surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183620-1999-00012 |
| MDR Report Key | 221498 |
| Report Source | 05 |
| Date Received | 1999-04-28 |
| Date of Report | 1999-04-28 |
| Date of Event | 1999-01-11 |
| Date Mfgr Received | 1999-04-08 |
| Date Added to Maude | 1999-05-05 |
| 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 | HQX |
| Date Received | 1999-04-28 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 214791 |
| Manufacturer | BIO-VASCULAR, INC. |
| Manufacturer Address | 2575 UNIVERSITY AVE. ST. PAUL MN 551141024 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1999-04-28 |