BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOOT CHOICE THERAPEUTIC DEVICE

    MDR report key: 1151683 · Received September 4, 2008

    Report

    Report Number
    1528424-2008-00003
    Event Type
    Injury
    Date Received
    September 4, 2008
    Date of Event
    March 19, 2006
    Report Date
    September 4, 2008
    Manufacturer
    YAS HEALTHY FITNESS CO. LTD.
    Product Code
    ISA
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    (B) (6) COMPLAINED THAT THE FOOT CHOICE THERAPEUTIC DEVICE CAUSED SEVERE BURNS ON THE SOLES OF BOTH OF HIS FEET THAT RESULTED IN THE NEED FOR MEDICAL ATTENTION AND HOSPITALIZATION.

    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. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| O