BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE

    MDR report key: 7936648 · Received October 4, 2018

    Report

    Report Number
    2438477-2018-00050
    Event Type
    Injury
    Date Received
    October 4, 2018
    Date of Event
    August 5, 2018
    Report Date
    October 4, 2018
    Manufacturer
    ZHENJIANG ASSURE MEDICAL EQUIPMENT CO LTD
    Product Code
    IOR
    UDI-DI
    00822383140414
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DRIVE DEVILBISS HEALTHCARE IS THE INITIAL IMPORTER OF THE PRODUCT WHICH IS A WHEELCHAIR. END-USER DISPOSED OF THE UNIT BUT PROVIDED SOME PHOTOS. THE END-USER REPORTED THAT TAPED UP THE ARMS OF THE WHEELCHAIR WHEN HE NOTICED THAT THE PLASTIC ON THE ARMS SPLIT. HE ALSO NOTED THE CHAIR WAS NOT LEVEL. HE CONTINUED TO USE THE CHAIR AND HAD AN INCIDENT. END-USER REPORTED THAT THE CHAIR SPREAD APART AND THE WHEELS WENT OUT FROM UNDER HIM AS HE TRIED TO USE THE WHEELCHAIR. HE FELL AND HIT THE DRESSER. HE WENT TO THE URGENT CARE AND WAS DIAGNOSED WITH BROKEN RIBS #4 & #5 ON THE LEFT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776980 DRIVE MANUAL WHEELCHAIR IOR ZHENJIANG ASSURE MEDICAL EQUIPMENT CO LTD SSP118FA-SF 00822383140414

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR