MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1999-01-29 for PREFORMED OCU-GUARD SUPPLE OG-2020SF manufactured by Bio-vascular, Inc..
[142987]
The surgeon reported that on 04/17/1998, he performed an enucleation procedure using preformed ocu-guard supple as the orbital implant wrap to treat the pt for a blind, painful eye. On 06/26/1998, the surgeon reclosed tenon's capsule and conjunctiva over the hydroxyapetite orbital implant. On 06/27/1998, the pt presented with exposure of the ocu-guard and the surgeon closed with suture. He did not remove the ocu-guard wrapped orbital implant. He does not know if the ocu-guard contributed to the pt's complication. The surgeon then implanted a vaulted conformer prosthesis so the implant would not rub.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 2183620-1999-00005 |
MDR Report Key | 208589 |
Report Source | 05 |
Date Received | 1999-01-29 |
Date of Report | 1999-01-28 |
Date of Event | 1998-06-26 |
Date Mfgr Received | 1999-01-18 |
Date Added to Maude | 1999-02-05 |
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 | 1999-01-29 |
Model Number | OG-2020SF |
Catalog Number | OG-2020SF |
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 | 202457 |
Manufacturer | BIO-VASCULAR, INC. |
Manufacturer Address | 2575 UNIVERSITY AVE. ST. PAUL MN 551141024 US |
Baseline Brand Name | OCU-GUARD |
Baseline Generic Name | ORBITAL IMPLANT WRAP |
Baseline Model No | OG-2020SFN |
Baseline Catalog No | OG-2020SFN |
Baseline ID | NA |
Baseline Device Family | OCU-GUARD |
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 | 1999-01-29 |