BEUDAMED
    FDA Adverse Event Other Summary report: N

    EMSI 2001 TENS

    MDR report key: 1660568 · Received April 9, 2010

    Report

    Report Number
    2938471-2010-00001
    Event Type
    Other
    Date Received
    April 9, 2010
    Date of Event
    March 2, 2010
    Report Date
    March 29, 2010
    Manufacturer
    AMERICAN BANTEX
    Product Code
    BTM
    PMA / PMN Number
    K071624
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN TESTED WITHOUT ANY DEFECTS FOUND. IN THE INSTRUCTIONS FOR THE DEVICE, THE FIRST LINE ITEM INSTRUCTS THE USER TO "MAKE CERTAIN STIMULATION DEVICE IS OFF PRIOR TO APPLYING OR REMOVING ELECTRODES." SIMILAR INSTRUCTIONS ARE ALSO GIVEN FOR THE ELECTRODE PADS. UNDER THE REMOVAL AND STORAGE SECTION THE USER IS ADVISED TO "TURN OFF ELECTRO-THERAPY DEVICE."

    Description of Event or Problem · 1

    HUSBAND PLACES CALL TO REP TO COMPLAIN ABOUT BATTERIES AND LABELING OF BATTERIES/UNIT. HUSBAND STATES THAT AFTER REPLACING ELECTRODE/BATTERY IN UNIT THAT WIFE STILL FELT NO STIMULATION AND UNIT WOULD NOT TURN ON. HUSBAND TOLD REP THAT HE PUT ELECTRODES ON HIS WIFE, CONNECTED LEADS TO ELECTRODES, LEADS TO UNIT AND CONTINUED TO TURN UP THE DIALS AS HIGH AS THEY WOULD GO TO SEE IF WIFE WOULD FEEL STIMULATION. WITH UNIT TURNED AS HIGH AS IT WOULD GO AND UNIT STILL ATTACHED TO WIFE - OPENS UNIT REMOVES BATTERY, NOTICES HE DID NOT REMOVE PLASTIC TAMPER PROOF SEAL. REMOVES PLASTIC COVERING FROM BATTERY AND PLACES BATTERY BACK INTO UNIT. THE PT IMMEDIATELY RECEIVES AN EXTREME PAINFUL JOLT OF ELECTROSTIMULATION AS THE UNIT WAS NOT TURNED OFF/ REMOVED FROM HER BODY BEFORE PUTTING BATTERY BACK INTO UNIT. HUSBAND UPSET THAT THERE WERE NO WARNINGS ON UNIT OR BATTERY TO MAKE SURE UNIT IS TURNED OFF BEFORE PUTTING IN BATTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMSI 2001 TENS TENS BTM AMERICAN BANTEX 2001

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other