BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIRAGEL

    MDR report key: 103440 · Received July 3, 1997

    Report

    Report Number
    1218813-1997-00001
    Event Type
    Injury
    Date Received
    July 3, 1997
    Date of Event
    January 1, 1997
    Report Date
    July 1, 1997
    Manufacturer
    MIRA, INC.
    Product Code
    HQJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PT WAS REPORTED TO HAVE A LARGE ORBITAL MASS OF THE EYE (PREVIOUSLY) SURGICALLY REPAIRED FOR A DETACHMENT IN 1986. IT WAS FOUND THAT EXPLANT USED IN THE 1986 SURGICAL PROCEDURE HAD DISINTEGRATED CAUSING THE SWELLING. PT HAD CORRECTIVE SURGERY VIA ASPIRATION TO REMOVE MOST OF THIS IMPLANT. REPORT WAS VIA LETTER FROM M.D. PERFORMING LATEST PROCEDURE, ORIGINAL M.D. WHO PERFORMED THE DETACHMENT SURGERY WAS NOT IDENTIFIED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention