BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCU-GARD

    MDR report key: 496093 · Received November 14, 2003

    Report

    Report Number
    2183620-2003-00046
    Event Type
    Injury
    Date Received
    November 14, 2003
    Report Date
    October 15, 2003
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    MTZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERWENT ENUCLEATION PROCEDURE (DATE KNOWN) FOLLOWED BY IMPLANTATION OF HYDROXYAPATITE ORBITAL PROSTHESIS IMPLANT ALONG WITH OCU-GARD ORTIBAL IMPLANT WRAP. AT APPROXIMATELY 8 MONTHS POST-IMPLANT, PATIENT PRESENTED WITH EXPOSURE, REQUIRING MULTIPLE REPAIRS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention HYDROXYAPATITE ORBITAL PROSTHESIS.