BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAKEMI DIAMOND SELECT 3500 COMFO

    MDR report key: 1338215 · Received March 7, 2009

    Report

    Report Number
    MW5010229
    Event Type
    Malfunction
    Date Received
    March 7, 2009
    Date of Event
    December 20, 2008
    Report Date
    March 7, 2009
    Manufacturer
    TAKEMI SELECT WHOLESALE OUTLET
    Product Code
    KMN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PRODUCT BROKE DOWN FOR THE 2ND TIME. COMPANY WILL NOT PAY TO FIX IT CAUSING ME TO NEED BEDREST ON THREE SEPARATE OCCASIONS DUE TO BACK PROBLEMS THAT THEY ADVERTISE ON THEIR SITE AS BEING FDA APPROVED. THE LINK AND LOGO ARE THERE ALTHOUGH I AM UNABLE TO FIND THEM LISTED HERE AS A MEMBER OR SOMEONE THAT HAS BEEN APPROVED. DOSE: 15 MINUTES. FREQUENCY: EVERY OTHER DAY. DATES OF USE: 2008. DIAGNOSIS: STRESS AND STRAIN ON BACK DUE TO ACCIDENT. PAIN IN BACK DUE TO WORK. TOO MANY TO LIST, VARIOUS DOCTORS ETC... NOT REALLY RELEVANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAKEMI DIAMOND SELECT 3500 COMFO MASSAGE CHAIR KMN TAKEMI SELECT WHOLESALE OUTLET ULTRA TOUCH 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other