BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THE FLEX BELT

    MDR report key: 5382732 · Received January 21, 2016

    Report

    Report Number
    8020867-2015-00022
    Event Type
    Injury
    Date Received
    January 21, 2016
    Date of Event
    November 1, 2015
    Report Date
    November 24, 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

    ROOT CAUSE OF THE COMPLAINT COULD NOT BE ESTABLISHED. NO INDEPENDENT MEDICAL RECORD OR COMPLETED MANUFACTURER MEDICAL QUESTIONNAIRE WERE PROVIDED TO BIO-MEDICAL RESEARCH LTD AS PART OF THE INVESTIGATION INTO THE COMPLAINT. ON REVIEW OF THE COMPLAINT, THE SENIOR CLINICAL SCIENTIST (BIO-MEDICAL RESEARCH LTD.) ADVISED THAT THE USER MAY HAVE AN UNDERLYING HERNIA OR WEAKNESS WITH THE ABDOMINAL WALL PRIOR TO USE. THE DEVICE WAS TESTED AND FOUND TO BE OPERATING WITHIN SPECIFICATION, HOWEVER, THE DEVICE USAGE HISTORY SHOWED THAT NO SESSIONS HAD BEEN PERFORMED USING THIS DEVICE. NOTE: DATE OF EVENT IS BEST ESTIMATE BASED ON INFORMATION RECEIVED BY BIO-MEDICAL RESEARCH LTD.

    Description of Event or Problem · 1

    BIO-MEDICAL RESEARCH LTD. WAS NOTIFIED ON (B)(6) 2015 OF A COMPLAINT REGARDING THE FLEX BELT (PART NUMBER 0399-5060). A FEMALE CUSTOMER HAD REPORTED THAT THE BELT FELT UNCOMFORTABLE AND THAT IT APPEARED THAT HER NAVEL HAD MOVED. HER DOCTOR HAS DIAGNOSED A HERNIA. NO MEDICAL REPORT HAS BEEN SUPPLIED TO BIO-MEDICAL RESEARCH LTD.. THE CUSTOMER HAD PREVIOUSLY USED THE BELT UP TO 3 TIMES PER DAY FOR SHORT PERIODS. THE CUSTOMER HAD LAST USED THE BELT APPROXIMATELY 4 MONTHS AGO AND CANNOT USE THE BELT NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42950 THE FLEX BELT POWERED MUSCLE STIMULATOR NGX BIO-MEDICAL RESEARCH LTD 399

    Patients

    Seq Age Sex Outcome Treatment
    1 Other