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 NI * manufactured by Bio-vascular, Inc..
[159285]
After previous evisceration surgery, patient complained of poor fit and movement of ocular prosthesis. Ocu-guard (flat configuration) was used in a subsequent surgery to wrap the orbital implant in 1999. Patient then presented with wound dehiscence, inflammation and bleeding. Underwent repair surgeries of two dehiscences on 12/07/1998, 03/18/1999, and 04/15/1999. Received a mucous membrane graft on 06/09/1999. Unable to wear ocular prosthesis. Presented with another wound dehiscence and inflammation on 08/03. 1999.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183620-1999-00017 |
| MDR Report Key | 236199 |
| Report Source | 05 |
| Date Received | 1999-08-16 |
| Date of Report | 1999-08-13 |
| Date of Event | 1998-12-07 |
| Date Mfgr Received | 1999-08-03 |
| Device Manufacturer Date | 1998-02-01 |
| 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 | NI |
| Catalog Number | * |
| Lot Number | OGSP-98B24 |
| ID Number | * |
| Device Expiration Date | 2003-02-24 |
| 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 | 228906 |
| Manufacturer | BIO-VASCULAR, INC. |
| Manufacturer Address | 2575 UNIVERSITY AVE. ST. PAUL MN 551141024 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 1999-08-16 |