BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLENDERTONE FLEX

    MDR report key: 5382446 · Received January 21, 2016

    Report

    Report Number
    8020867-2015-00010
    Event Type
    Injury
    Date Received
    January 21, 2016
    Date of Event
    April 5, 2011
    Report Date
    April 8, 2011
    Manufacturer
    BIO-MEDICAL RESEARCH LTD
    Product Code
    NGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONSUMER DID NOT PROVIDE A MEDICAL REPORT. DEVICE WAS EVALUATED AND NO FAILURE WAS DETECTED. DEVICE WAS FOUND TO BE OPERATING WITHIN SPECIFICATION. AT THIS TIME, NO LINK COULD BE ESTABLISHED BETWEEN THE DEVICE AND THE ADVERSE EVENT REPORTED. UPON RETROSPECTIVE REVIEW, THIS ISSUE WAS DETERMINED TO BE REPORTABLE AS AN MDR.

    Description of Event or Problem · 1

    CONSUMER REPORTED PAIN IN BACK AFTER A FEW DAYS OF USE. DOCTOR PRESCRIBED INJECTIONS AND ADVISED HER TO STOP USING THE PRODUCT. AFTER A FEW DAYS, THE PAIN STOPPED. SHE RETRIED THE DEVICE AFTER A COUPLE OF MONTHS AND SHE FELT A PAIN IN HER BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40619 SLENDERTONE FLEX POWERED MUSCLE STIMULATOR NGX BIO-MEDICAL RESEARCH LTD 510

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other