OCU-GUARD *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1999-08-16 for OCU-GUARD * manufactured by Bio-vascular, Inc..

Event Text Entries

[136012] Patient received a new orbital implant wrapped with ocu-guard to replace a previously-inserted, too-small orbital implant, following previous enucleation surgery. The date of the ocu-guard implant was 1999. On 02/10/1999 and 01/18/1999, the patient presented with wound dehiscence which was repaired by primary closure, and on 05/05/1990 for a mucous membrane graft. The dehiscences involved both the conjuctiva and tenon's capsule ("layer"). Patient is still unable to wear a permanent prosthesis.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2183620-1999-00019
MDR Report Key236195
Report Source05
Date Received1999-08-16
Date of Event1999-02-10
Date Mfgr Received1999-08-03
Device Manufacturer Date1997-10-01
Date Added to Maude1999-08-20
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameOCU-GUARD
Generic NameORBITAL IMPLANT WRAP
Product CodeMTZ
Date Received1999-08-16
Model Number*
Catalog Number*
Lot NumberOGS-97J28-075
ID Number*
Device Expiration Date2002-10-28
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagY
Date RemovedA
Device Sequence No1
Device Event Key228903
ManufacturerBIO-VASCULAR, INC.
Manufacturer Address2575 UNIVERSITY AVE. #180 ST. PAUL MN 55114 US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 1999-08-16

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