BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOOT CHOICE THERAPEUTIC DEVICE

    MDR report key: 1151676 · Received September 4, 2008

    Report

    Report Number
    1528424-2008-00008
    Event Type
    Injury
    Date Received
    September 4, 2008
    Date of Event
    March 23, 2006
    Report Date
    September 4, 2008
    Manufacturer
    YAS HEALTHY FITNESS CO. LTD.
    Product Code
    ISA
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    WV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    (B) (6) CONTACTED CUSTOMER SERVICE AND STATED THAT SHE WANTED TO RETURN THE FOOT CHOICE THERAPEUTIC DEVICE FOR A REFUND BECAUSE HER HUSBAND RECEIVED BURNS AND WAS NOT AWARE THAT IT USED INFRARED HEAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOOT CHOICE THERAPEUTIC DEVICE FOOT CHOICE FOOT MASSAGER ISA YAS HEALTHY FITNESS CO. LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other