BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLENDERTONE FACE

    MDR report key: 5382432 · Received January 21, 2016

    Report

    Report Number
    8020867-2015-00026
    Event Type
    Injury
    Date Received
    January 21, 2016
    Date of Event
    January 4, 2014
    Report Date
    April 23, 2014
    Manufacturer
    BIO-MEDICAL RESEARCH LTD
    Product Code
    NFO
    PMA / PMN Number
    K103031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDICAL REPORTS WERE PROVIDED TO BIO-MEDICAL RESEARCH LTD AS PART OF THE INVESTIGATION. THE DEVICE WAS RETURNED TO BIO-MEDICAL RESEARCH LTD AND TESTING PERFORMED SHOWED THE DEVICE PERFORMED PER IT'S SPECIFICATION. ADVERSE REACTIONS OF SKIN IRRITATION AND BURNS BENEATH THE ELECTRODES HAVE BEEN REPORTED WITH THE USE OF POWERED MUSCLE STIMULATORS. THIS KNOWN RISK HAS BEEN DOCUMENTED IN THE RISK ASSESSMENT AND ALSO USER INSTRUCTIONS FOR USE OF THE DEVICE - 'A SMALL NUMBER OF ISOLATED SKIN REACTIONS HAVE BEEN REPORTED BY PEOPLE USING MUSCLE STIMULATION DEVICES, INCLUDING ALLERGIES, A PROLONGED REDDENING OF THE SKIN AND ACNE'. THE DATE OF EVENT PROVIDED IS BEST ESTIMATE BASED ON PURCHASE DATE AND DATE OF EVENT. THIS COMPLAINT HAS BEEN REPORTED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINTS REPRESENTING EVENTS THAT ARE MDR REPORTABLE.

    Description of Event or Problem · 1

    BIO-MEDICAL RESEARCH LTD. WAS NOTIFIED ON (B)(6) 2014 VIA EMAIL BY IT'S CALL CENTRE THAT THEY HAD RECEIVED A COMPLAINT REGARDING THE SLENDERTONE FACE. THE FEMALE CUSTOMER HAS PURCHASED THE DEVICE ON (B)(6) 2014 AND HAD USED IT THREE TIMES FOR APPROXIMATELY 10 MINUTES EACH. THE CUSTOMER REPORTED THAT SHE RECEIVED PAINS IN HER THROAT AND NOSE AREA, ALONG WITH A BURNING SENSATION. THE CUSTOMER REPORTED THAT HER FACE BECAME RED AND INFLAMED. SHE VISITED HER DOCTOR AND WAS PRESCRIBED WITH ANTI INFLAMMATORY MEDICATION. SHE STOPPED USING THE PRODUCT FOR THREE WEEKS AND TRIED IT AGAIN ON (B)(6) AND 22 FOR 10 MINUTES EACH TIME. SHE AGAIN STARTED TO EXPERIENCE A BURNING SENSATION IN THE THROAT AND NOSE AREA. SHE REPORTED THAT SHE STOPPED USING THE DEVICE DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41557 SLENDERTONE FACE FACIAL STIMULATOR NFO BIO-MEDICAL RESEARCH LTD 371

    Patients

    Seq Age Sex Outcome Treatment
    1 Other