OCU-GUARD NI *

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 NI * manufactured by Bio-vascular, Inc..

Event Text Entries

[159285] After previous evisceration surgery, patient complained of poor fit and movement of ocular prosthesis. Ocu-guard (flat configuration) was used in a subsequent surgery to wrap the orbital implant in 1999. Patient then presented with wound dehiscence, inflammation and bleeding. Underwent repair surgeries of two dehiscences on 12/07/1998, 03/18/1999, and 04/15/1999. Received a mucous membrane graft on 06/09/1999. Unable to wear ocular prosthesis. Presented with another wound dehiscence and inflammation on 08/03. 1999.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2183620-1999-00017
MDR Report Key236199
Report Source05
Date Received1999-08-16
Date of Report1999-08-13
Date of Event1998-12-07
Date Mfgr Received1999-08-03
Device Manufacturer Date1998-02-01
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 NumberNI
Catalog Number*
Lot NumberOGSP-98B24
ID Number*
Device Expiration Date2003-02-24
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagY
Date RemovedA
Device Sequence No1
Device Event Key228906
ManufacturerBIO-VASCULAR, INC.
Manufacturer Address2575 UNIVERSITY AVE. ST. PAUL MN 551141024 US


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 1999-08-16

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