BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIRAGEL EYE IMPLANT

    MDR report key: 32913 · Received May 10, 1996

    Report

    Report Number
    MW4001190
    Event Type
    Malfunction
    Date Received
    May 10, 1996
    Report Date
    April 24, 1996
    Manufacturer
    M.I.R.A.,INC.
    Product Code
    HQJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    HUSBAND HAD RPTR'S DEVICE IMPLANTED IN HIS EYE FOR RETINAL REATTACHMENT 11 YEARS AGO. RECENT DR VISIT CONFIRMED THAT THE PRODUCT WAS DISINTEGRATING AND COULD NOT BE REMOVED SURGICALLY WITHOUT NERVE DAMAGE TO THE EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIRAGEL EYE IMPLANT EYE IMPLANT HQJ M.I.R.A.,INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO