BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNI(TM) MULTIUSE HANDPIECE

    MDR report key: 2874082 · Received December 14, 2012

    Report

    Report Number
    1419951-2012-00008
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    November 14, 2012
    Report Date
    December 21, 2012
    Manufacturer
    TRIMEDYNE, INC.
    Product Code
    GEX
    PMA / PMN Number
    K962632
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    ACCORDING TO THE CUSTOMER, THE HANDPIECE BURNED THROUGH THE INSULATION THE FIRST TIME THEY USED IT. THIS INFORMATION IS DOCUMENTED AS REPORTED TO TRIMEDYNE, INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNI(TM) MULTIUSE HANDPIECE LASER FIBER GEX TRIMEDYNE, INC. 20471-HP

    Patients

    Seq Age Sex Outcome Treatment
    1