OCU-GUARD UNK

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 2000-01-24 for OCU-GUARD UNK manufactured by Bio-vascular.

Event Text Entries

[161888] Pt underwent an underscribed surgical intervention for ocular melanoma on 11/22/1999 and rec'd an ocu-guard wrap. In 01/2000, he experienced suture line dehiscence and required "repair".
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2183620-2000-00002
MDR Report Key259843
Report Source05
Date Received2000-01-24
Date of Report2000-01-24
Date of Event2000-01-01
Date Mfgr Received2000-01-14
Date Added to Maude2000-01-28
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
Manufacturer ContactMARY SOBCINSKI
Manufacturer Street2575 UNIVERSITY AVE
Manufacturer CityST PAUL MN 55114
Manufacturer CountryUS
Manufacturer Postal55114
Manufacturer Phone6516033703
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameOCU-GUARD
Generic NameORBITAL IMPLANT WRAP
Product CodeMTZ
Date Received2000-01-24
Model NumberUNK
Catalog NumberUNK
Lot NumberUNK
ID NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagY
Date RemovedU
Device Sequence No1
Device Event Key251645
ManufacturerBIO-VASCULAR
Manufacturer Address2575 UNIVERSITY AVE. ST. PAUL MN 55114 US


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2000-01-24

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