BEUDAMED
    FDA Adverse Event Other Summary report: N

    MIRAGEL SCLERAL BUCKLING ELEMENT

    MDR report key: 29084 · Received December 27, 1995

    Report

    Report Number
    MW1008008
    Event Type
    Other
    Date Received
    December 27, 1995
    Date of Event
    September 10, 1995
    Report Date
    November 10, 1995
    Manufacturer
    MIRA, INC.
    Product Code
    HQJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    "INROSION" OF BUCKLING ELEMENT HALFWAY THROUGH EYEWALL. CURRENTLY NO SEVERE VISUAL PROBLEM BUT HIGH LIKELIHOOD OF LATER RETINAL DETACHMENT OR BLOCKAGE OF VISION BY BUCKLING ELEMENT. SURGERY WAS DONE ELSEWHERE ON 10/8/95.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIRAGEL SCLERAL BUCKLING ELEMENT SCLERAL BUCKLING ELEMENT HQJ MIRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other