OCU-GUARD UNK *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 03,05 report with the FDA on 2003-10-08 for OCU-GUARD UNK * manufactured by Synovis Surgical Innovations.

Event Text Entries

[317660] In 2000 (exact date unknown), patient underwent enucleation procedure followed by implantation of hydroxyapatite orbital prosthesis implant along with ocu-guard orbital implant wrap. At eighteen weeks post-op patient presented with 10 mm conjunctival melt over ocu-guard wrap. At five months post-op patient underwent conjunctivoplasty surgery. Patient post-op status: patient retained orbital implant.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2183620-2003-00022
MDR Report Key488971
Report Source03,05
Date Received2003-10-08
Date of Report2003-09-08
Date Mfgr Received2003-09-08
Date Added to Maude2003-10-16
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Manufacturer ContactPAUL HARTZELL
Manufacturer Street2575 UNIVERSITY AVE W
Manufacturer CityST. PAUL MN 551141024
Manufacturer CountryUS
Manufacturer Postal551141024
Manufacturer Phone6516033732
Manufacturer G1SYNOVIS SURGICAL INNOVATIONS
Manufacturer Street2575 UNIVERSITY AVE W
Manufacturer CityST. PAUL MN 55114102
Manufacturer CountryUS
Manufacturer Postal Code55114 1024
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameOCU-GUARD
Generic NameORBITAL IMPLANT WRAP
Product CodeMTZ
Date Received2003-10-08
Model NumberUNK
Catalog Number*
Lot NumberUNK
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagY
Date Removed*
Device Sequence No1
Device Event Key477760
ManufacturerSYNOVIS SURGICAL INNOVATIONS
Manufacturer Address2575 UNIVERSITY AVE. W ST. PAUL MN 551141024 US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2003-10-08

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