BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIM PLUS ELECTRONIC ACCUPUNCTURE

    MDR report key: 440258 · Received January 29, 2003

    Report

    Report Number
    MW1027388
    Event Type
    Injury
    Date Received
    January 29, 2003
    Date of Event
    November 1, 2002
    Report Date
    January 29, 2003
    Manufacturer
    STIM PLUS LMS ENTERPRISES
    Product Code
    BWK
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    FAULTY UNIT CONNECTION OPENINGS DEFECTIVE. UNIT SHORTS OUT, TELEPHONE DOES NOT STAY PUT IN OPENINGS, FALLS OUT. CAN CAUSE ELECTROCUTION. SHOULD BE RECALLED AND TAKEN OFF THE MARKET. LMS STIM PLUS UNIT CONNECTIONS FAULTY AND DANGEROUS. TELEPHONE CORD AND PIN FALLS OUT OF UNIT. CAN CAUSE SERIOUS DAMAGE TO PACEMAKERS. CAN CAUSE SERIOUS PROBLEMS IN PERSON WITH HEART PROBLEMS. LMS STIM PLUS REFUSES TO SEND PT BRAND NEW UNIT IN A-1 WORKING CONDITION.

    Description of Event or Problem · 1

    UNIT MALFUNCTIONS BY SHORTING OUT. USER CAN SEE THAT THE CYLINDER IS OFF CENTER AND DOESN'T ACCOMODATE THE PIN ON THE WIRE. HAS CALLED DISTRIBUTOR AND THEY WILL SEND USER A REPLACEMENT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STIM PLUS ELECTRONIC ACCUPUNCTURE TO TREAT PAIN AND ARTHRITIS ETC BWK STIM PLUS LMS ENTERPRISES STIM PLUS SW 1030 BODY CHECK *

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Life Threatening CLASSED SAME AS TENS UNIT.