BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLENDERTONE ABS S7

    MDR report key: 5382408 · Received January 21, 2016

    Report

    Report Number
    8020867-2015-00029
    Event Type
    Injury
    Date Received
    January 21, 2016
    Date of Event
    June 7, 2015
    Report Date
    November 23, 2015
    Manufacturer
    BIO-MEDICAL RESEARCH LTD.
    Product Code
    NGX
    PMA / PMN Number
    K100320
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE (SERIAL NUMBER (B)(4)) WAS TESTED AND FOUND TO BE OPERATING WITHIN EXPECTED OUTPUT PARAMETER RANGES. THE DEVICE HISTORY RECORD WAS REVIEWED AND THE DEVICE HAS BEEN CONFIRMED TO HAVE MET IT'S SPECIFICATIONS. ON REVIEW OF THE MEDICAL REPORT SUPPLIED TO THE MANUFACTURER, PRE-EXISTING MEDICAL CONDITIONS OF BULIMIA AND STRESS FACTORS WERE DETAILED. AT THIS TIME, NO LINK HAS BEEN ESTABLISHED BETWEEN THE ADVERSE EVENT AND THE USE OF THE SLENDERTONE DEVICE.

    Description of Event or Problem · 1

    BIO-MEDICAL RESEARCH LTD. WAS NOTIFIED ON JUNE 10, 2015 VIA EMAIL BY IT'S CALL CENTRE THAT THEY HAD RECEIVED A COMPLAINT REGARDING THE SLENDERTONE ABS (PART NUMBER 0390-2008). THE FEMALE CUSTOMER HAD PURCHASED THE DEVICE ON (B)(6) 2015. THE CUSTOMER HAD REPORTED ON USING THE DEVICE 4 TIMES, SHE ENCOUNTERED ISSUES WITH HER HEARTBEAT (RAPID HEARTBEAT). SHE WAS IN HOSPITAL FOR 3 DAYS AND RECEIVED A FULL CHECK-UP. DURING HER HOSPITALIZATION, HER CONDITION WAS REVIEWED AND THE PATIENT WAS DIAGNOSED AS HAVING DYSPNEA WITH HEART PALPITATIONS AND CHEST PAINS. THE PATIENT RECOVERED BUT WAS ADVISED AGAINST FUTURE USE OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41420 SLENDERTONE ABS S7 POWERED MUSCLE STIMULATOR NGX BIO-MEDICAL RESEARCH LTD. 398

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Hospitalization