BEUDAMED
    FDA Adverse Event Death Summary report: N

    EPIX XL

    MDR report key: 204033 · Received November 30, 1998

    Report

    Report Number
    2182686-1998-00007
    Event Type
    Death
    Date Received
    November 30, 1998
    Date of Event
    September 10, 1998
    Report Date
    November 6, 1998
    Manufacturer
    EMPI, INC.
    Product Code
    GZJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    PT WAS USING TENS DEVICE AT TIME OF INCIDENT. THE PT DIED IN THE EMERGENCY ROOM. CAUSE OF DEATH UNKNOWN BY EMPI DESPITE REPEATED ATTEMPTS TO LEARN IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPIX XL TENS GZJ EMPI, INC. 995 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death