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 |