BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEX BELT

    MDR report key: 5384859 · Received January 22, 2016

    Report

    Report Number
    8020867-2015-00030
    Event Type
    Injury
    Date Received
    January 22, 2016
    Date of Event
    July 31, 2015
    Report Date
    September 3, 2015
    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 REPORTED SUFFERING CHEST PAIN WHILE USING HER FLEX BELT DEVICE. HER CARDIOLOGIST ADVISED HER SHE DID NOT HAVE CORONARY DISEASE. NO MEDICAL REPORT WAS PROVIDED BY THE CONSUMER. DEVICE WAS EVALUATED AND PASSED ALL TESTING. THERE WERE NO FAULTS FOUND. DEVICE HISTORY RECORDS FOR THE DEVICE SHOWED NO MAJOR ISSUES IN THE MANUFACTURING PROCESS FOR THIS DEVICE. UPON RETROSPECTIVE REVIEW, THIS ISSUE WAS DETERMINED TO BE REPORTABLE AS AN MDR.

    Description of Event or Problem · 1

    CONSUMER REPORTED USING THE FLEX BELT DEVICE ONE TIME FOR 7 MINUTES AND BEGAN HAVING SEVERE CHEST PAINS. SHE TURNED OFF THE UNIT AND STATED 'THIS RESULTED IN A HEART ATTACK'. SHE VISITED HER CARDIOLOGIST AND AFTER BEING TESTED WAS ADVISED SHE DID NOT HAVE CORONARY DISEASE. THE CONSUMER REQUESTED A REFUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45551 FLEX BELT POWERED MUSCLE STIMULATOR NGX BIO-MEDICAL RESEARCH LTD 399

    Patients

    Seq Age Sex Outcome Treatment
    1 Other