BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLENDERTONE ABS MALE

    MDR report key: 5382470 · Received January 21, 2016

    Report

    Report Number
    8020867-2015-00021
    Event Type
    Injury
    Date Received
    January 21, 2016
    Date of Event
    April 1, 2013
    Report Date
    November 1, 2013
    Manufacturer
    BIO-MEDICAL RESEARCH LTD
    Product Code
    NGX
    PMA / PMN Number
    K070142
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONSUMER REPORTED HE DEVELOPED AN UMBILICAL HERNIA AFTER USING THE SLENDERTONE DEVICE. HE INFORMED BMR THAT HIS DOCTOR ADVISED IT MAY HAVE BEEN DUE TO THE USE OF THE DEVICE. NO MEDICAL REPORT WAS PROVIDED BY THE CONSUMER AND THE DEVICE WAS NOT RETURNED FOR TESTING DESPITE SEVERAL ATTEMPTS BY BMR TO HAVE THE DEVICE RETURNED, THEREFORE NO ROOT CAUSE COULD BE ESTABLISHED. BMRS (B)(4) ADVISED HE BELIEVES THE USER MAY HAVE AN UNDERLYING HERNIA OR WEAKNESS WITH THE ABDOMINAL WALL PRIOR TO USE. AT THIS TIME NO DIRECT LINK BETWEEN THE USE OF THE DEVICE AND THE SYMPTOMS REPORTED COULD BE ESTABLISHED. UPON RETROSPECTIVE REVIEW, THIS ISSUE WAS DETERMINED TO BE REPORTABLE AS AN MDR.

    Description of Event or Problem · 1

    CONSUMER REPORTED HE DEVELOPED AN UMBILICAL HERNIA AFTER USING THE DEVICE OVER SEVERAL MONTHS. CONSUMER REPORTED THAT AFTER CONSULTING HIS DOCTOR, THE DOCTOR ADVISED IT MAY BE DUE TO THE SLENDERTONE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42266 SLENDERTONE ABS MALE POWERED MUSCLE STIMULATOR NGX BIO-MEDICAL RESEARCH LTD 392

    Patients

    Seq Age Sex Outcome Treatment
    1 Other