MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1999-01-22 for OCU-GUARD SUPPLE UNK manufactured by Bio-vascular, Inc..
[175614]
The surgeon reported that she performed a frontalis suspension procedure using ocu-guard supple on 08/10/1998. On 08/20/1998, the pt experienced draining pus, yellow material, from incision site. The ocu-guard supple was explanted. It was reported that no harm has come to the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183620-1999-00003 |
| MDR Report Key | 207318 |
| Report Source | 05 |
| Date Received | 1999-01-22 |
| Date of Report | 1999-01-22 |
| Date of Event | 1998-08-20 |
| Date Mfgr Received | 1998-10-23 |
| Date Added to Maude | 1999-01-26 |
| 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 | OCU-GUARD SUPPLE |
| Generic Name | ORBITAL IMPLANT WRAP |
| Product Code | MTZ |
| Date Received | 1999-01-22 |
| 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 | 201233 |
| Manufacturer | BIO-VASCULAR, INC. |
| Manufacturer Address | 2575 UNIVERSITY AVE. ST. PAUL MN 551141024 US |
| Baseline Brand Name | OCU-GUARD SUPPLE |
| Baseline Generic Name | ORBITAL IMPLANT WRAP |
| Baseline Model No | UNK |
| Baseline Catalog No | UNK |
| Baseline ID | NA |
| Baseline Device Family | 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 | 1999-01-22 |