BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIRAGEL

    MDR report key: 486396 · Received September 20, 2003

    Report

    Report Number
    MW1029528
    Event Type
    Injury
    Date Received
    September 20, 2003
    Date of Event
    June 28, 2000
    Report Date
    September 2, 2003
    Manufacturer
    MIRA, INC.
    Product Code
    HQJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MS, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    THE MIRAGEL IMPLANT INCURRED SWELLING AND DEGRADATION OVER THE COURSE OF SEVERAL YEARS. IMPLANT WAS REMOVED AND FOUND TO BE SWOLLEN AND FRAGMENTED. PT HAS LOST A SIGNIFICANT AMOUNT OF VISION IN THEIR RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIRAGEL SCLERAL BUCKLE IMPLANT HQJ MIRA, INC. 907 H164

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other| S