BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLENDERTONE SYSTEM ABS

    MDR report key: 5383234 · Received January 21, 2016

    Report

    Report Number
    8020867-2015-00015
    Event Type
    Injury
    Date Received
    January 21, 2016
    Date of Event
    July 1, 2012
    Report Date
    August 17, 2012
    Manufacturer
    BIO-MEDICAL RESEARCH LTD
    Product Code
    NGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS RETURNED FOR TESTING AND PASSED TESTING AS PER THE TEST METHOD REQUIREMENTS. NO MEDICAL HISTORY OR MEDICAL REPORT ON THE CONSUMER WAS MADE AVAILABLE. NO LINK COULD BE DETERMINED BETWEEN THE INCIDENT AND THE DEVICE. THE CONSUMER HAD BEEN USING THE DEVICE FOR A PROLONGED AND DAILY TIME PERIOD BEFORE THE INCIDENT WITHOUT EXPERIENCING ANY ADVERSE EVENT. UPON RETROSPECTIVE REVIEW, THIS ISSUE WAS DETERMINED TO BE REPORTABLE AS AN MDR.

    Description of Event or Problem · 1

    REPORT WAS RECEIVED FROM OUR DISTRIBUTOR IN (B)(4) THAT A CONSUMER SUFFERED A BRAIN HAEMORRHAGE WHILE HE WAS USING THE SLENDERTONE ABS. CONSUMER WAS HOSPITALIZED FOR 2 WEEKS. HE USED THE UNIT TWICE A DAY, EACH DAY FOR 2 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41784 SLENDERTONE SYSTEM ABS POWERED MUSCLE STIMULATOR NGX BIO-MEDICAL RESEARCH LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other