BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIRAGEL

    MDR report key: 289071 · Received August 8, 2000

    Report

    Report Number
    1218813-2000-00002
    Event Type
    Injury
    Date Received
    August 8, 2000
    Date of Event
    July 1, 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
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    MD REPORTING THAT PT HAD "SYMPTOMS" DUE TO LARGE MASS THAT MIGRATED FORWARD AFTER A PREVIOUS IMPLANTATION. ALL MATERIAL WAS REMOVED FROM EYE AND PT HAS BEEN COMFORTABLE POST SURGERY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention