BEUDAMED
    FDA Adverse Event Summary report: N

    STIMULATOR

    MDR report key: 29582 · Received January 30, 1996

    Report

    Report Number
    MW1008225
    Date Received
    January 30, 1996
    Report Date
    January 30, 1996
    Manufacturer
    SELF-CARE, INC.
    Product Code
    GZJ
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    MFR'S AD SAYS "IMMEDIATE PAIN RELIEF WITHOUT DRUGS." THE AD WAS TAKEN FROM PREVENTION MAGAZINE. (JANUARY ISSUE). RPTR WANTS THE FDA TO ENFORCE THE 1976 DEVICE ACT AGAINST THE STIMULATOR AND TAKE IT OFF THE MARKET. THE CO IS MAKING FALSE CLAIMS REGARDING THIS DEVICE. RPTR'S UNDERSTANDING IS THAT THE FDA CONFISCATED 16000 OF THE STIMULATORS. (*)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STIMULATOR STIMULATOR GZJ SELF-CARE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 *