BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EHM CODETRON

    MDR report key: 2576394 · Received June 3, 2009

    Report

    Report Number
    2576394
    Event Type
    Malfunction
    Date Received
    June 3, 2009
    Date of Event
    March 4, 2009
    Report Date
    June 3, 2009
    Manufacturer
    BJW REHABILITATION ONTARIO INC
    Product Code
    ETN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ONE OF THE UNITS PURCHASED (SERIAL # (B)(4)) WAS FOUND NOT TO FUNCTION AS EXPECTED WHEN USED IN THE FIELD. IT WAS ALSO FOUND NOT TO CHARGE PROPERLY. CONSEQUENTLY, AN ADDITIONAL SIX UNITS (SERIAL #S (B)(4)) WERE FOUND TO HAVE SIMILAR PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EHM CODETRON TRANS ELECTRICAL NERVE STIMULATOR ETN BJW REHABILITATION ONTARIO INC 902-C

    Patients

    Seq Age Sex Outcome Treatment
    1