BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE

    MDR report key: 12678163 · Received October 21, 2021

    Report

    Report Number
    2438477-2021-00056
    Event Type
    Injury
    Date Received
    October 21, 2021
    Date of Event
    October 12, 2021
    Report Date
    October 21, 2021
    Manufacturer
    HANGZHOU DUNLI MEDICAL INSTRUMENTS CO.,LTD
    Product Code
    FNL
    UDI-DI
    00822383211534
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DRIVE DEVILBISS HEALTHCARE IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A BED. THE UNIT WAS NOT RETURNED FOR EVALUATION. WE WILL SUBMIT A FOLLOW-UP REPORT WHEN ADDITIONAL INFORMATION IS AVAILABLE. THE DEVICE HAD A CRACK IN THE FOOTBOARD. THE USER HAS DIABETES AND CUT HER LEG ON THE FOOT BOARD. THE DEVICE IS ALSO LEANING ON THE LEFT SIDE. WHILE ASLEEP THE USER FELL OUT AND FRACTURED HER HIP. SHE HAS HAD MEDICAL ATTENTION. SHE IS IN A HYPO CHAMBER FOR THE LACERATION DUE TO THE DIABETES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1567876 DRIVE SEMI ELECTRIC BED FNL HANGZHOU DUNLI MEDICAL INSTRUMENTS CO.,LTD 15030BV-HR 00822383211534

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention