BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLENDERTONE BOTTOM S7

    MDR report key: 5382473 · Received January 21, 2016

    Report

    Report Number
    8020867-2015-00028
    Event Type
    Injury
    Date Received
    January 21, 2016
    Date of Event
    September 16, 2015
    Report Date
    November 23, 2015
    Manufacturer
    BIO-MEDICAL RESEARCH LTD
    Product Code
    NGX
    PMA / PMN Number
    K072294
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONSUMER REPORTED DEVELOPING SCIATICA PAIN AFTER USING THE DEVICE. HER CHIROPRACTOR ADVISED SHE HAS BEEN TREATING THE CONSUMER SINCE (B)(6) 2015 FOR AN UNSPECIFIED CONDITION. SHE ALSO ADVISED THE HYPERTONICITY IN HER RIGHT PIRIFORMIS MUSCLE WAS EVIDENT ALONG WITH PAIN IN THE SCIATIC NERVE AND THAT IS WAS POSSIBLE THE USE OF THE DEVICE WAS CAUSING THE BUTTOCK MUSCLE TO BECOME HYPERTONIC AND IRRITATE THE SURROUNDING NERVES. TESTING OF THE DEVICE SHOWED THE DEVICE WAS OPERATING AS INTENDED AND NO ISSUE COULD BE FOUND. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE DEVICE SHOWED NO MAJOR ISSUES DURING MANUFACTURE. UPON RETROSPECTIVE REVIEW, THIS ISSUE WAS DETERMINED TO BE REPORTABLE AS AN MDR.

    Description of Event or Problem · 1

    CONSUMER REPORTED DEVELOPING SCIATICA ON HER RIGHT HAND SIDE FROM MID BUTTOCK DOWN HER LEG. SHE HAS BEEN USING THE UNIT 3 TIMES A WEEK FOR 3 WEEKS, THE PAIN GOES AWAY WHEN SHE STOPS USING THE UNIT. THE PAIN IS ON ONE SIDE ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41660 SLENDERTONE BOTTOM S7 POWERED MUSCLE STIMULATOR NGX BIO-MEDICAL RESEARCH LTD 396

    Patients

    Seq Age Sex Outcome Treatment
    1 Other