BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE

    MDR report key: 10103485 · Received May 29, 2020

    Report

    Report Number
    2438477-2018-00066
    Event Type
    Injury
    Date Received
    May 29, 2020
    Date of Event
    October 1, 2018
    Report Date
    May 29, 2020
    Manufacturer
    JAN MAO INDUSTRIES CO., LTD.
    Product Code
    ITJ
    UDI-DI
    00822383138107
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DRIVE DEVILBISS IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A ROLLATOR. THIS REPORT IS BEING TENDERED IN AN OVERABUNDANCE OF CAUTION IN RESPONSE TO AN MDR REGRESSION ANALYSIS. THE END-USER WAS SITTING IN THE DRIVEWAY ON THE UNIT WHEN THE ENTIRE LEFT SIDE REPORTEDLY COLLAPSED. HE FELL,HITTING HIS HEAD ON THE BLACKTOP. THE DEVICE WAS RETURNED FOR EVALUATION. THE ITEM # 10243 CLEVERLITE WALKER WAS RETURNED UNDER RMA # (B)(4) DUE TO THE LEG BENDING. THE UNIT SHOWS SIGNS OF NORMAL WEAR AND MULTIPLE COMPONENTS HAVE RUST ON IT. THE BRAKES AND THE FOLDING HINGE FUNCTION CORRECTLY. POSSIBLE ROOT CAUSE FOR THIS FAILURE WAS THAT THE USER WAS SITTING ON A LEVEL SURFACE CAUSING AN UNBALANCED LOAD ON THE LEGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565275 DRIVE ROLLATOR ITJ JAN MAO INDUSTRIES CO., LTD. 10243 00822383138107

    Patients

    Seq Age Sex Outcome Treatment
    1