BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLENDERTONE ABS

    MDR report key: 5382468 · Received January 21, 2016

    Report

    Report Number
    8020867-2015-00020
    Event Type
    Injury
    Date Received
    January 21, 2016
    Date of Event
    April 11, 2013
    Report Date
    April 17, 2013
    Manufacturer
    BIO-MEDICAL RESEARCH LTD
    Product Code
    NGX
    PMA / PMN Number
    K100320
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONSUMER DID NOT PROVIDE A MEDICAL REPORT. EVALUATION OF THE DEVICE SHOWED NO ISSUE WITH THE DEVICE. DEVICE HISTORY RECORDS SHOWED NO MAJOR ISSUES WITHIN THE BATCH. NO LINK HAS BEEN ESTABLISHED AT THIS TIME BETWEEN THE USE OF 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

    EVENT WAS REPORTED BY CONSUMERS DAUGHTER ON BEHALF OF HER MOTHER. THE CONSUMER CLAIMED AFTER USING THE DEVICE 4 TIMES, SHE SUFFERED CHEST PAINS AND WAS TAKEN TO HOSPITAL. AT THE HOSPITAL SHE WAS TOLD OF POSSIBLE MUSCLE AND NERVE DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42265 SLENDERTONE ABS POWERED MUSCLE STIMULATOR NGX BIO-MEDICAL RESEARCH LTD 399

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other