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..
[173234]
The surgeon reported that she performed a frontalis suspension procedure using ocu-guard supple on 07/31/1998. The pt experienced swelling and draining of yellow material from incision site on 10/05/1998. This was treated by lancing and draining the incision. The ocu-guard supple began to extrude and on 11/02/1998 the ocu-guard supple was explanted. The surgeon reported the pt encountered a post-operative infection and it may not be related to the use of the ocu-guard supple device. It was reported that no harm has come to the pt.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 2183620-1999-00002 |
MDR Report Key | 207370 |
Report Source | 05 |
Date Received | 1999-01-22 |
Date of Report | 1999-01-22 |
Date of Event | 1998-10-05 |
Date Mfgr Received | 1998-10-19 |
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 | 201285 |
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 |