MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2001-10-05 for OCU-GUARD OG-1818SE * manufactured by Bio-vascular, Inc..
[209033]
In 2001, pt underwent enucleation for a blind and painful eye. An ocu-guard orbital implant wrap was applied over the medpor prosthesis. Later in 2001, the pt presented with conjunctival dehiscense with multiple areas of anterior exposure. About three weeks after this, the ocu-guard and medpro prosthesis were removed and replaced with an acrylic sphere. The pt's condition is reported as stable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183620-2001-00018 |
| MDR Report Key | 357398 |
| Report Source | 05 |
| Date Received | 2001-10-05 |
| Date of Report | 2001-09-14 |
| Date of Event | 2001-06-26 |
| Date Mfgr Received | 2001-09-14 |
| Device Manufacturer Date | 1999-02-01 |
| Date Added to Maude | 2001-10-25 |
| 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 |
| Manufacturer Contact | MARY SOBCINSKI |
| Manufacturer Street | 2575 UNIVERSITY AVE W |
| Manufacturer City | ST PAUL MN 55114 |
| Manufacturer Country | US |
| Manufacturer Postal | 55114 |
| Manufacturer Phone | 6516033703 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OCU-GUARD |
| Generic Name | ORBITAL IMPLANT WRAP |
| Product Code | MTZ |
| Date Received | 2001-10-05 |
| Model Number | OG-1818SE |
| Catalog Number | * |
| Lot Number | 525892 |
| ID Number | * |
| Device Expiration Date | 2004-02-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 346619 |
| Manufacturer | BIO-VASCULAR, INC. |
| Manufacturer Address | 2575 UNIVERSITY AVE. W ST. PAUL MN 551141024 US |
| Baseline Brand Name | OCU-GUARD |
| Baseline Generic Name | ORBITAL IMPLANT WRAP |
| Baseline Model No | OG-1818SE |
| Baseline Catalog No | * |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2001-10-05 |