BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERDOT

    MDR report key: 10694444 · Received October 16, 2020

    Report

    Report Number
    3014127689-2020-00003
    Event Type
    Malfunction
    Date Received
    October 16, 2020
    Date of Event
    September 10, 2020
    Report Date
    September 16, 2020
    Manufacturer
    SMARTMISSIMO TECHNOLOGIES PTE LTD
    Product Code
    NGX
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED AN EVENT WHILE USING THE DUO PRODUCT, WHICH CONTAINS TWO DEVICE UNITS. BOTH DEVICES WERE RETURNED FOR EVALUATION; THE CUSTOMER IDENTIFIED AND REPORTED THE ISSUE REGARDING ONE DEVICE ONLY. THE REPORTED EVENT WAS CONFIRMED; DEVICE PERFORMANCE TESTS SHOWED HIGH IMPEDANCE IN THE SUSPECT DEVICE. INSPECTION OF THE DEVICE IDENTIFIED THAT THE MAGNETIC BUTTON EDGE ABNORMALLY PIERCED THE PCB AND WAS IN CONTACT WITH THE INNER COPPER FOIL. THIS CONTACT CAUSED A SHORT CIRCUIT RESULTING IN ABNORMAL OUTPUT. THE INVESTIGATION ALSO IDENTIFIED THAT THE ELECTRODE PADS WERE USED BEYOND THE USE-LIFE. THIS TYPE OF EVENT WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT WHEN USING OF ONE OF HIS DEVICES IN THE DUO HE EXPERIENCED A BURNING SENSATION; CUSTOMER REPORTED THAT HE HAD NOT EXPERIENCED THIS ISSUE WITH THE OTHER UNIT IN THE DUO. CUSTOMER REPORTED THAT WHEN HE REMOVED THE ELECTRODE PAD HE OBSERVED TWO BURN MARKS ON HIS BACK. THE CUSTOMER REPORTED THAT THE BURN DID NOT REQUIRE MEDICAL ATTENTION AND THAT HE SELF-TREATED WITH LOTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1155465 POWERDOT POWERED MUSCLE STIMULATOR NGX SMARTMISSIMO TECHNOLOGIES PTE LTD POWERDOT 2.0 1801

    Patients

    Seq Age Sex Outcome Treatment
    1