MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 03,05 report with the FDA on 2003-10-08 for OCU-GUARD UNK * manufactured by Synovis Surgical Innovations.
[317659]
In 2001 (exact date unk), pt underwent enucleation procedure followed by implantation of hydroxyapatite orbital prosthesis implant along with ocu-guard orbital implant wrap. At tweleve months post-op pt presented with 8 mm conjunctive melt over ocu-guard wrap; pt underwent intervention with fascia graft. Pt post-op status: pt retained orbital implant.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183620-2003-00036 |
| MDR Report Key | 488966 |
| Report Source | 03,05 |
| Date Received | 2003-10-08 |
| Date of Report | 2003-09-08 |
| Date Mfgr Received | 2003-09-08 |
| Date Added to Maude | 2003-10-16 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | PAUL HARTZELL |
| Manufacturer Street | 2575 UNIVERSITY AVE W |
| Manufacturer City | ST. PAUL MN 551141024 |
| Manufacturer Country | US |
| Manufacturer Postal | 551141024 |
| Manufacturer Phone | 6516033732 |
| Manufacturer G1 | SYNOVIS SURGICAL INNOVATIONS |
| Manufacturer Street | 2575 UNIVERSITY AVE W |
| Manufacturer City | ST. PAUL MN 55114102 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55114 1024 |
| 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 | 2003-10-08 |
| Model Number | UNK |
| Catalog Number | * |
| Lot Number | UNK |
| ID Number | * |
| 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 | 477755 |
| Manufacturer | SYNOVIS SURGICAL INNOVATIONS |
| Manufacturer Address | 2575 UNIVERSITY AVE W ST. PAUL MN 551141024 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2003-10-08 |