BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE MEDICAL

    MDR report key: 3030179 · Received March 28, 2013

    Report

    Report Number
    2438477-2013-00007
    Event Type
    Injury
    Date Received
    March 28, 2013
    Date of Event
    January 31, 2013
    Report Date
    February 26, 2013
    Manufacturer
    WUXI KANGQIANG INDUSTRIAL EQUIPMENT CO. LTD.
    Product Code
    ITJ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    (B)(4) HAS RECEIVED A PATIENT COMPLAINT ABOUT AN INCIDENT INVOLVING A WALKER ALLEGEDLY IMPORTED AND DISTRIBUTED BY (B)(4). CLAIMANT'S DAUGHTER STATED HER MOTHER WAS EXITING THE ELEVATOR WHEN ONE OF THE WALKER LEGS SNAPPED BELOW THE JOINT. CLAIMANT FELL AND HIT HER HEAD AND BRUISED HER SHOULDER. CLAIMANT IS CURRENTLY IN A NURSING HOME DUE TO A BROKEN CLAVICLE AND CRACKED RIBS. THIS MDR REPORT IS BASED ON THE COMPLAINT FROM CLAIMANT'S DAUGHTER AND THE INFORMATION PROVIDED BY THE (B)(4) SUPPLIER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128719 DRIVE MEDICAL MECHANICAL WALKER ITJ WUXI KANGQIANG INDUSTRIAL EQUIPMENT CO. LTD. RTL10261RD NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention