MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1999-01-29 for PREFORMED OCU-GUARD SUPPLE UNK manufactured by Bio-vascular, Inc..
[19141494]
The surgeon reported that on 05/15/1998, he performed an enucleation procedure using preformed ocu-guard supple as the orbital implant wrap to treat the pt for a blind, painful eye. On 06/19/1998, the pt presented with exposure of the hydroxyapetite orbital implant, which the preformed ocu-guard supple is used to cover. On 10/22/1998, the surgeon reclosed tenon's capsule and conjunctiva over the hydroxyapetite orbital implant where it was exposed. The same reclosure procedure was performed on 11/02/1998. On 11/11/1998, the surgeon removed the preformed ocu-guard supple orbital wrap and the implant. The surgeon does not know if the preformed ocu-guard supple contributed to the complication that his pt experienced. The pt is currently doing well after replacement with an acrylic sphere.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183620-1999-00004 |
| MDR Report Key | 208592 |
| Report Source | 05 |
| Date Received | 1999-01-29 |
| Date of Report | 1999-01-28 |
| Date of Event | 1998-06-19 |
| Date Mfgr Received | 1999-01-18 |
| Date Added to Maude | 1999-02-05 |
| 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 | PREFORMED OCU-GUARD SUPPLE |
| Generic Name | ORBITAL IMPLANT WRAP |
| Product Code | MTZ |
| Date Received | 1999-01-29 |
| 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 | V |
| Device Sequence No | 1 |
| Device Event Key | 202460 |
| 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 | 1999-01-29 |