BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE

    MDR report key: 10043976 · Received May 11, 2020

    Report

    Report Number
    2438477-2017-00090
    Event Type
    Injury
    Date Received
    May 11, 2020
    Date of Event
    January 30, 2017
    Report Date
    May 11, 2020
    Manufacturer
    HL CORP (SHENZHEN)
    Product Code
    ITJ
    UDI-DI
    00822383183589
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DRIVE DEVILBISS IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A KNEE WALKER. THIS REPORT IS BEING TENDERED IN AN OVERABUNDANCE OF CAUTION IN RESPONSE TO AN MDR REGRESSION ANALYSIS. THE DEVICE'S SEAT POST FAILED WHICH CAUSED THE CUSTOMER TO FALL. SHE HIT HER HEAD AND RECEIVED A MINOR CONCUSSION. SINCE THIS INCIDENT A DESIGN CHANGE UNDER PC#297 (2016/2017) HAS ADDRESSED THE SEAT POST ISSUE. THE SERIAL NUMBER PROVIDED SHOWS THAT THE UNIT WAS MANUFACTURED IN 2013, PRIOR TO THE CHANGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508330 DRIVE KNEE WALKER ITJ HL CORP (SHENZHEN) 790 00822383183589

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention