BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIRAGEL

    MDR report key: 289720 · Received August 11, 2000

    Report

    Report Number
    1218813-2000-00003
    Event Type
    Injury
    Date Received
    August 11, 2000
    Date of Event
    December 2, 1998
    Report Date
    August 11, 2000
    Manufacturer
    MIRA INC
    Product Code
    HQJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    IMPAIRMENT OF VISION IN RIGHT EYE DUE TO DEFICIENCIES AND PROBLEMS WITH SCLERAL"EXOPLANT"(MIRAGEL).

    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