PREFORMED OCU-GUARD SUPPLE OG-2020SF

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 1999-01-29 for PREFORMED OCU-GUARD SUPPLE OG-2020SF manufactured by Bio-vascular, Inc..

Event Text Entries

[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


MAUDE Entry Details

Report Number2183620-1999-00005
MDR Report Key208589
Report Source05
Date Received1999-01-29
Date of Report1999-01-28
Date of Event1998-06-26
Date Mfgr Received1999-01-18
Date Added to Maude1999-02-05
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 NamePREFORMED OCU-GUARD SUPPLE
Generic NameORBITAL IMPLANT WRAP
Product CodeMTZ
Date Received1999-01-29
Model NumberOG-2020SF
Catalog NumberOG-2020SF
Lot NumberUNK
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagY
Date RemovedA
Device Sequence No1
Device Event Key202457
ManufacturerBIO-VASCULAR, INC.
Manufacturer Address2575 UNIVERSITY AVE. ST. PAUL MN 551141024 US
Baseline Brand NameOCU-GUARD
Baseline Generic NameORBITAL IMPLANT WRAP
Baseline Model NoOG-2020SFN
Baseline Catalog NoOG-2020SFN
Baseline IDNA
Baseline Device FamilyOCU-GUARD
Baseline Shelf Life ContainedY
Baseline Shelf Life [Months]60
Baseline PMA FlagN
Baseline 510K PMNY
Premarket NotificationK973552
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 1999-01-29

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