BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLENDERTONE FACE

    MDR report key: 5382442 · Received January 21, 2016

    Report

    Report Number
    8020867-2015-00017
    Event Type
    Injury
    Date Received
    January 21, 2016
    Date of Event
    January 8, 2013
    Report Date
    January 15, 2013
    Manufacturer
    BIO-MEDICAL RESEARCH LTD
    Product Code
    NGX
    PMA / PMN Number
    K103031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONSUMER REPORTED A RASH AFTER USING HER FACE UNIT FOR 3 MONTHS. SHE SUFFERS FROM ALLERGIES AND CANNOT USE SCENTED PRODUCTS OR PERFUMES ON HER SKIN. SHE ASSUMES SHE MAY BE ALLERGIC TO THE PADS. THE DEVICE WAS RETURNED TO THE PLACE OF PURCHASE AND THE SERIAL NUMBER WAS NOT AVAILABLE, THEREFORE NO EVALUATION OF THE DEVICE OR IT DEVICE HISTORY RECORD COULD BE COMPLETED. UPON RETROSPECTIVE REVIEW, THIS ISSUE WAS DETERMINED TO BE REPORTABLE AS AN MDR. DEVICE WAS RETURNED TO PLACE OF PURCHASE.

    Description of Event or Problem · 1

    CONSUMER ONLY USED THE DEVICE ONCE OR TWICE A WEEK DUE TO KNOWN HISTORY OF ALLERGIES. AFTER 3 MONTHS OF USE SHE REPORTED RASH BURNS ON HER SKIN. SHE USED HYDROCORTISONE CREAM AND EUMOVATE OINTMENT PRESCRIBED BY HER DOCTOR ON PREVIOUS OCCASIONS FOR OTHER EVENTS NOT RELATED TO THE USE OF SLENDERTONE DEVICES. SHE DID NOT SEE A DOCTOR FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41559 SLENDERTONE FACE POWERED MUSCLE STIMULATOR NGX BIO-MEDICAL RESEARCH LTD 371

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other