BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSTEM ABS

    MDR report key: 5382445 · Received January 21, 2016

    Report

    Report Number
    8020867-2015-00012
    Event Type
    Injury
    Date Received
    January 21, 2016
    Date of Event
    January 20, 2012
    Report Date
    January 27, 2012
    Manufacturer
    BIO-MEDICAL RESEARCH LTD
    Product Code
    NGX
    PMA / PMN Number
    K070142
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR INVESTIGATION AND NO MEDICAL REPORT WAS PROVIDED AS PART OF THE INVESTIGATION. BASED ON THE LIMITED INFORMATION AVAILBLE, NO LINK COULD BE ESTABLISHED BETWEEN THE DEVICE AND THE ADVERSE EVENT REPORTED AT THIS TIME. UPON RETROSPECTIVE REVIEW, THIS ISSUE WAS DETERMINED TO REPORTABLE AS AN MDR.

    Description of Event or Problem · 1

    CONSUMER REPORTED HEARING A RIB SNAP AND FELT SEVERE PAIN AS SHE WAS INCREASING THE INTENSITY OF THE DEVICE. CONSUMER STATED TO BMR THAT AN X-RAY COMPLETED BY HER DOCTOR SHOWED A RIB WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41456 SYSTEM ABS POWERED MUSCLE STIMULATOR NGX BIO-MEDICAL RESEARCH LTD 391

    Patients

    Seq Age Sex Outcome Treatment
    1 Other