BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIRAGEL

    MDR report key: 188961 · Received September 22, 1998

    Report

    Report Number
    1218813-1998-00009
    Event Type
    Injury
    Date Received
    September 22, 1998
    Date of Event
    January 1, 1998
    Report Date
    September 14, 1998
    Manufacturer
    MIRA INC.
    Product Code
    HQJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    COMPLICATIONS FROM MIRAGEL SPONGE; PT CLAIMS A FEEL OF FOREIGN MATERIAL IN EYE. RE-IMPLANTED AND PT NOW IS RECOVERED. ORIGINAL IMPLANTATION WAS SIX TO EIGHT YEARS AGO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIRAGEL Implant SCLERAL BUCKLING COMPONENT HQJ MIRA INC. 904 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention