BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSTEM ULTRA

    MDR report key: 5382447 · Received January 21, 2016

    Report

    Report Number
    8020867-2015-00014
    Event Type
    Injury
    Date Received
    January 21, 2016
    Date of Event
    April 1, 2012
    Report Date
    April 5, 2012
    Manufacturer
    BIO-MEDICAL RESEARCH LTD
    Product Code
    NGX
    PMA / PMN Number
    K100320
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONSUMER DID NOT PROVIDE A MEDICAL REPORT AND RETURNED HER DEVICE TO THE PLACE OF PURCHASE, THEREFORE NO TESTING COULD BE COMPLETED ON THE DEVICE. DEVICE HISTORY RECORDS COULD NOT BE REVIEWED AS NO SERIAL NUMBER FOR THE DEVICE WAS AVAILABLE. BASED ON THE LIMITED INFORMATION AVAILABLE, 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 SHE BEGAN SHAKING ALL OVER HER BODY WHEN USING THE UNIT. SHE WENT TO THE HOSPITAL AND REQUIRED MUSCLE RELAXING MEDICATION TO RECOVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40620 SYSTEM ULTRA POWERED MUSCLE STIMULATOR NGX BIO-MEDICAL RESEARCH LTD 517

    Patients

    Seq Age Sex Outcome Treatment
    1 Other