BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOOT CHOICE FOOT MASSAGER

    MDR report key: 1616644 · Received February 4, 2010

    Report

    Report Number
    1528424-2010-00001
    Event Type
    Other
    Date Received
    February 4, 2010
    Date of Event
    January 1, 2009
    Report Date
    February 3, 2010
    Manufacturer
    YAS HEALTHY FITNESS CO. LTD.
    Product Code
    ISA
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    MD NOTIFIED CUSTOMER SERVICE VIA MAIL THAT SHE HAD BURNED HER TOES WHILE USING THE FOOT CHOICE FOOT MASSAGER. AFTER A FEW WEEKS, HER TOES BECAME INFECTED AND SHE HAD TO HAVE THE TIP OF HER 2ND TOE AMPUTATED. MD SAID THAT SHE HAD VERY POOR CIRCULATION AND POOR FEELING IN HER FEET. SHE STATED THAT SHE USED THE HEAT FUNCTION FOR ENTIRELY TOO LONG OF A TIME FRAME AND FELT THE BURNS WERE HER FAULT. THIS HAPPENED IN (B)(6) 2009. THE UNIT WAS PURCHASED IN 2007 AND SHE HAD USED IT FREQUENTLY FOR ALMOST 2 YEARS. SHE CONTINUED TO USE THE UNIT EVEN AFTER THE INCIDENT WITHOUT THE HEAT FEATURE BECAUSE SHE LOVED THE MASSAGE. THE ONLY REASON THAT SHE CONTACTED CUSTOMER SERVICE IS BECAUSE HER UNIT STOPPED WORKING, SO SHE RETURNED IT TO SEE IF IT COULD BE FIXED AS SHE WOULD LIKE TO CONTINUE USING IT. SHE STATED THAT HER TOES HAVE HEALED AND YOU CAN HARDLY BARELY TELL ANYTHING HAPPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOOT CHOICE FOOT MASSAGER FOOT CHOICE FOOT MASSAGER ISA YAS HEALTHY FITNESS CO. LTD. A2775 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other