BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENS UNIT

    MDR report key: 6002767 · Received October 4, 2016

    Report

    Report Number
    MW5065207
    Event Type
    Malfunction
    Date Received
    October 4, 2016
    Date of Event
    July 27, 2016
    Report Date
    October 3, 2016
    Manufacturer
    PAIN MANAGEMENT TECHNOLOGIES
    Product Code
    NUH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT REPORTED A BURN CAUSED BY A TENS UNIT FOR USE BY THE PT WITH THE HELP OF PRIVATE CARE GIVER. THIS EVENT WAS NOT REPORTED TO THE (B)(4) UNTIL 09/28/2016 DUE TO F/U BY CONTACT CARE PROVIDER. BURNS WERE NOT NOTICEABLE BY THE TIME THEY WERE REPORTED TO THE (B)(4). ITEM WAS REMOVED FROM USE. THERAPY START DATE: (B)(6) 2016. THERAPY END DATE: (B)(6) 2016. DIAGNOSIS OR REASON FOR USE: BACK PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649851 TENS UNIT TENS UNIT NUH PAIN MANAGEMENT TECHNOLOGIES

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other