BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE

    MDR report key: 7039335 · Received November 16, 2017

    Report

    Report Number
    2438477-2017-00087
    Event Type
    Injury
    Date Received
    November 16, 2017
    Date of Event
    October 3, 2017
    Report Date
    October 27, 2017
    Manufacturer
    HL CORP. (SHENZHEN)
    Product Code
    ITJ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    (B)(4) IS THE INITIAL IMPORTER OF THE MEDICAL DEVICE INVOLVED IN THIS INCIDENT. IT IS A BARIATRIC ROLLATOR WITH A WEIGHT CAP OF 500 POUNDS. THE END-USER WAS ABOVE THE WEIGHT CAP. THE END-USER WENT TO SIT DOWN ON THE ROLLATOR. SHE SAID THE BRAKES DID NOT ENGAGE. THE ROLLATOR SLID OUT FROM UNDER HER AND SHE FELL. SHE WAS TRANSPORTED TO THE HOSPITAL WHERE SHE WAS DIAGNOSED WITH HERNIATED DISCS. HER HUSBAND ADJUSTED THE BRAKES AT THE HOSPITAL AND THE ROLLATOR IS WORKING FINE. THE BRAKES WERE NOT ENGAGED/SET UP PROPERLY. WE ARE GETTING THE UNIT BACK AND REPLACING IT WITH ANOTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    816138 DRIVE ROLLATOR ITJ HL CORP. (SHENZHEN) 10215RD-1

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention