BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE

    MDR report key: 9207701 · Received October 18, 2019

    Report

    Report Number
    2438477-2019-00067
    Event Type
    Injury
    Date Received
    October 18, 2019
    Date of Event
    August 28, 2019
    Report Date
    October 18, 2019
    Manufacturer
    HANGZHOU FUYANG HONGWEI METAL PRODUCT LTD CO
    Product Code
    ITJ
    UDI-DI
    00822383290331
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    KY, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    (B)(4) HEALTHCARE IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A ROLLATOR. WE HAVE NOT RETRIEVED THE DEVICE FOR EVALUATION. END-USER IS REQUESTING COMPENSATION FOR (B)(4) BILLS. END-USER WAS SITTING ON THE DEVICE. WHEN SHE GOT UP THE HANDGRIP REPORTEDLY SLIPPED COMPLETELY FORWARD. SHE WENT FORWARD WITH THE GRIP AND HIT THE FLOOR. SHE INJURED HER RIGHT SIDE AND ANKLE. THE FIRE DEPARTMENT ASSISTED HER AND BROUGHT HER TO THE ER. SHE WAS DIAGNOSED WITH A BROKEN ANKLE AND FIBULA, GIVEN A BOOT AND DIRECTED TO SEE A SPECIALIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1002182 DRIVE ROLLATOR ITJ HANGZHOU FUYANG HONGWEI METAL PRODUCT LTD CO 10257BL-1 00822383290331

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention