BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOMCARE

    MDR report key: 2585147 · Received May 17, 2012

    Report

    Report Number
    MW5025467
    Event Type
    Malfunction
    Date Received
    May 17, 2012
    Report Date
    May 17, 2012
    Manufacturer
    MICROCURRENT TECH INC.
    Product Code
    FSM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    OUR FACILITY IS USING THE CUSTOMCARE FSM DEVICE. OVER THE PAST FEW MONTHS WE HAVE HAD SEVERAL PATIENTS REPORT THAT THEY ARE FEELING LIKE THEY HAVE BEEN SHOCKED DURING THE TREATMENT. THE FEELING HAS BEEN REPORTED AS A UNCOMFORTABLE FEELING ALL THE WAY TO A STRONG SENSE OF DISCOMFORT THAT LEAVES RED MARKS ON THE SKIN. REASON FOR USE: PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOMCARE FSM MICROCURRENT TECH INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other