BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIRAGEL

    MDR report key: 293604 · Received August 8, 2000

    Report

    Report Number
    1218813-2000-00004
    Event Type
    Injury
    Date Received
    August 8, 2000
    Date of Event
    July 6, 2000
    Report Date
    August 8, 2000
    Manufacturer
    MIRA INC.
    Product Code
    HQJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    MD REPORTING THAT PT WAS COMPLAINING OF DOUBLE VISION AND DISCOMFORT. A RE-OPERATION DISCLOSED THAT THE IMPLANT HAD FRAGMENTED AND WAS REMOVED. ORIGINAL IMPLANTATION WAS 1990, DUE TO OCULAR TRAUMA TO RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIRAGEL SCLERAL BUCKLING COMPONENT HQJ MIRA INC. 908G UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention