MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1998-12-19 for PREFORMED OCU-GUARD SUPPLE UNK manufactured by Bio-vascular, Inc..
[117359]
The surgeon reported that on 10/15/1998, he performed an enucleation procedure due to the pt having no useful vision in that eye and the condition of the eye being painful to the pt. On 11/20/1998, the pt presented with exposue of the hydroxyapetite orbital implant, which the preformed ocu-guard supple is used to cover. On 12/16/1998, the surgeon put a dermis graft over the hydroxyapetite orbital implant. The preformed ocu-guard supple orbital wrap was not explanted. The surgeon does not attribute the incident to the use of the preformed ocu-guard supple product. The condition of the pt is currently stable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183620-1998-00011 |
| MDR Report Key | 203636 |
| Report Source | 05 |
| Date Received | 1998-12-19 |
| Date of Report | 1998-12-18 |
| Date of Event | 1998-11-20 |
| Date Mfgr Received | 1998-11-20 |
| Date Added to Maude | 1998-12-29 |
| 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 | PREFORMED OCU-GUARD SUPPLE |
| Generic Name | ORBITAL IMPLANT WRAP |
| Product Code | MTZ |
| Date Received | 1998-12-19 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| 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 | 197797 |
| Manufacturer | BIO-VASCULAR, INC. |
| Manufacturer Address | 2575 UNIVERSITY AVE ST. PAUL MN 551141024 US |
| Baseline Brand Name | PREFORMED OCU-GUARD SUPPLE |
| Baseline Generic Name | ORBITAL IMPLANT WRAP |
| Baseline Model No | UNK |
| Baseline Catalog No | UNK |
| Baseline ID | NA |
| Baseline Device Family | PREFORMED OCU-GUARD SUPPLE |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 60 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K973552 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1998-12-19 |