BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLENDERTONE ABS

    MDR report key: 5383256 · Received January 21, 2016

    Report

    Report Number
    8020867-2015-00018
    Event Type
    Injury
    Date Received
    January 21, 2016
    Date of Event
    January 24, 2013
    Report Date
    February 25, 2013
    Manufacturer
    BIO-MEDICAL RESEARCH LTD
    Product Code
    NGX
    PMA / PMN Number
    K100320
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RETURNED DEVICE PASSED TESTING AS PER TEST REQUIREMENTS. REVIEW OF DEVICE HISTORY RECORDS AT SUPPLIER SITE SHOWED NO MAJOR ISSUES IN THE MANUFACTURING PROCESS FOR THAT BATCH. NO MEDICAL REPORT WAS SUPPLIED BY THE CONSUMER. INSTRUCTION MANUAL DOS AND DONTS SECTION INDICATES 'A SMALL NUMBER OF ISOLATED SKIN REACTIONS HAVE BEEN REPORTED BY PEOPLE USING MUSCLE STIMULATION DEVICES....'. BASED ON THE LIMITED INFORMATION TO HAND, IT APPEARS THE CONSUMER MAY HAVE SUFFERED A KNOWN ADVERSE REACTION. UPON RETROSPECTIVE REVIEW, THIS ISSUE WAS DETERMINED TO BE REPORTABLE AS AN MDR.

    Description of Event or Problem · 1

    CONSUMER USED THE ABS BELT 3 TIMES AND NOTICED ITCHY SPOTS UNDER THE PADS. AFTER 3 WEEKS THE SPOTS TURNED BROWN AND BEGAN TO GO AWAY. HER DOCTOR PRESCRIBED AQUEOUS CREAM AND OINTMENT WHICH DID NOT HELP AND SO THEN PRESCRIBED STEROIDS, ANTIBIOTIC AND PIRITON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41788 SLENDERTONE ABS POWERED MUSCLE STIMULATOR NGX BIO-MEDICAL RESEARCH LTD 398

    Patients

    Seq Age Sex Outcome Treatment
    1 Other