BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIRAGEL

    MDR report key: 175437 · Received July 2, 1998

    Report

    Report Number
    1218813-1998-00007
    Event Type
    Injury
    Date Received
    July 2, 1998
    Date of Event
    September 1, 1993
    Report Date
    June 24, 1998
    Manufacturer
    MIRA INC
    Product Code
    HQJ
    Removal / Correction Number
    1013941
    Report Source
    Manufacturer report

    Narratives

    Description of Event or Problem · 1

    DIPLOPIA FOLLOWING SCLERAL BUCKLE PROCEDURE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIRAGEL Implant SCLERAL BUCKLING COMPONENT HQJ MIRA INC 906 H-340

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R