BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLENDERTONE ABS MALE

    MDR report key: 5382465 · Received January 21, 2016

    Report

    Report Number
    8020867-2015-00019
    Event Type
    Injury
    Date Received
    January 21, 2016
    Date of Event
    April 15, 2013
    Report Date
    April 15, 2013
    Manufacturer
    BIO-MEDICAL RESEARCH LTD
    Product Code
    NGX
    PMA / PMN Number
    K070142
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION AND WITHOUT A SERIAL NUMBER NO REVIEW OF THE DEVICE HISTORY RECORD COULD BE COMPLETED. CONSUMER PROVIDED LETTER FROM HIS DOCTORS STATING HE WAS SUFFERING FROM DIASTASIS RECTI ABDOMINIS BUT DID NOT CONFIRM THIS WAS CAUSED BY THE SLENDERTONE DEVICE. CONSUMER ADVISED HE HAD PURCHASED THE PRODUCT 9 YEARS PREVIOUS AND HAD BEEN USING IT FOR A LONG PERIOD OF TIME. AT THIS TIME, NO LINK HAS BEEN ESTABLISHED BETWEEN THE ADVERSE EVENT AND THE USE OF THE SLENDERTONE DEVICE. UPON RETROSPECTIVE REVIEW, THIS ISSUE WAS DETERMINED TO BE REPORTABLE AS AN MDR.

    Description of Event or Problem · 1

    CONSUMER ADVISED HE IS SUFFERING FROM A LUMP POKING THROUGH HIS RIBS. HE IS A PE TEACHER AND IS UNABLE TO EXERCISE HIS ABDOMINALS AND THIS IS AFFECTING HIS JOB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41658 SLENDERTONE ABS MALE POWERED MUSCLLE STIMULATOR NGX BIO-MEDICAL RESEARCH LTD 392

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other