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 * manufactured by Bio-vascular, Inc..
[136013]
Bilateral implants of ocu-guard into the lower eyelids to correct retraction (this is an unapproved use of this product), in 1999. In 1999, the ocu-guard was excised from the right lower lid and in 1999, it was excised from the left lower lid, because they were extruding. The problems resolved with excision.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183620-1999-00020 |
| MDR Report Key | 236202 |
| Report Source | 05 |
| Date Received | 1999-08-16 |
| Date of Report | 1999-08-13 |
| Date of Event | 1999-05-04 |
| Date Mfgr Received | 1999-08-03 |
| Device Manufacturer Date | 1997-10-01 |
| 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 | * |
| Catalog Number | * |
| Lot Number | OGS-97J28-077 |
| ID Number | * |
| Device Expiration Date | 2002-10-28 |
| 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 | 228909 |
| Manufacturer | BIO-VASCULAR, INC. |
| Manufacturer Address | 2575 UNIVERSITY AVE. #180 ST. PAUL MN 55114 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1999-08-16 |