BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCU-GUARD

    MDR report key: 488966 · Received October 8, 2003

    Report

    Report Number
    2183620-2003-00036
    Event Type
    Injury
    Date Received
    October 8, 2003
    Report Date
    September 8, 2003
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    MTZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 2001 (EXACT DATE UNK), PT UNDERWENT ENUCLEATION PROCEDURE FOLLOWED BY IMPLANTATION OF HYDROXYAPATITE ORBITAL PROSTHESIS IMPLANT ALONG WITH OCU-GUARD ORBITAL IMPLANT WRAP. AT TWELEVE MONTHS POST-OP PT PRESENTED WITH 8 MM CONJUNCTIVE MELT OVER OCU-GUARD WRAP; PT UNDERWENT INTERVENTION WITH FASCIA GRAFT. PT POST-OP STATUS: PT RETAINED ORBITAL IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCU-GUARD ORBITAL IMPLANT WRAP MTZ SYNOVIS SURGICAL INNOVATIONS UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Required Intervention HYDROXYAPATITE ORBITAL PROSTHESIS