MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2000-08-31 for OCU-GUARD UNK manufactured by Bio-vascular, Inc..
[181818]
In 2000, pt received an ocu-guard orbital implant wrap to repair a previously placed vicryl-wrapped hydroxyapatite sphere, which had extruded after enucleation. On 07/14/2000, the pt presented with conjunctival dehiscence over the ocu-guard. Per the surgeon's report, the dehiscence has been attributed to moderate trauma secondary to two previous surgeries. To date, the ocu-guard has not been explanted. The area is improving, the exposed area is reducing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183620-2000-00010 |
| MDR Report Key | 294271 |
| Report Source | 05 |
| Date Received | 2000-08-31 |
| Date of Report | 2000-08-31 |
| Date of Event | 2000-07-14 |
| Date Mfgr Received | 2000-08-22 |
| Date Added to Maude | 2000-09-07 |
| 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 | DEL STECKLER |
| Manufacturer Street | 2575 UNIVERSITY AVE. |
| Manufacturer City | ST. PAUL MN 55114 |
| Manufacturer Country | US |
| Manufacturer Postal | 55114 |
| Manufacturer Phone | 6516035200 |
| 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 | 2000-08-31 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| 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 | 284863 |
| 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 | 2000-08-31 |