BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOLDEN COMFORTER

    MDR report key: 2820834 · Received October 3, 2012

    Report

    Report Number
    2523995-2012-00003
    Event Type
    Malfunction
    Date Received
    October 3, 2012
    Date of Event
    June 19, 2012
    Report Date
    September 28, 2012
    Manufacturer
    GOLDEN TECHNOLOGIES, INC.
    Product Code
    INO
    PMA / PMN Number
    K880800
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    GOLDEN TECHNOLOGIES INC, OFFERED THE THERASAGE (K120254) FAR HEATING PAD AS AN OPTION ON CERTAIN MODELS OF THEIR CHAIRS. THE FAILURE IS IN THE FAR PAD AND NOT IN GOLDENS LIFT CHAIR. A SAFETY ALERT WAS ISSUED ON SEPTEMBER 21, 2012 BY GOLDEN TECHNOLOGIES FOR THE FAR HEATING SYSTEM USED INSIDE SOME OF GOLDEN TECHNOLOGIES CHAIRS. GOLDEN HAS ASKED ALL CONSUMERS TO UNPLUG THE THERASAGE HEATING PADS AND WILL PERMANENTLY DISABLE THE FAR SYSTEM. ADDITIONALLY GOLDEN HAS DISCONTINUED USE OF THE FAR PADS IN ANY AND ALL FUTURE PRODUCTS. THE SAFETY ALERTS DOES NOT INCLUDE GOLDENS STANDARD HEAT AND MESSAGE SYSTEMS.

    Description of Event or Problem · 1

    THE OPTICAL THERASAGE PADS HEATED UP AND BURNT SEVERAL HOLES IN THE CHAIRS CHASE PAD. NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GOLDEN COMFORTER LIFT CHAIR INO GOLDEN TECHNOLOGIES, INC. PR501

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK