BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-POR

    MDR report key: 38789 · Received September 10, 1996

    Report

    Report Number
    38789
    Event Type
    Injury
    Date Received
    September 10, 1996
    Date of Event
    August 30, 1996
    Report Date
    September 4, 1996
    Manufacturer
    POREX SURGICAL, INC.
    Product Code
    HPZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT RETURNED TO OR STATUS POST ENUCLEATION WITH 20 MM POLYETHYLENE IMPLANT OS ON 8/2/96. DIAGNOSIS OF EXTRUDING ORBITAL IMPLANT OS REQUIRING REPLACEMENT WITH A 15 MM SILICONE IMPLANT AND WOUND REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MED-POR Implant EYE SPHERE WITH CONFORMER HPZ POREX SURGICAL, INC. UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention