BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRSX5/WD86/ADULT/28FB/BH16/1255/U2222C/COM/U240 9153637785

    MDR report key: 6019591 · Received October 11, 2016

    Report

    Report Number
    3004766495-2016-00001
    Event Type
    Injury
    Date Received
    October 11, 2016
    Date of Event
    August 8, 2015
    Report Date
    October 12, 2016
    Manufacturer
    DANYANG JUMAO HEALTHCARE EQUIPMENT CO.,LTD.
    Product Code
    IOR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    S/N (B)(4),LOT 3021632-419,SHIP OUT ON 11/03/2012. CHECK THE INVENTORY IN WAREHOUSE AND FROM CUSTOMER SIDE,NO STOCK FOUND . CHECK DHR OF THIS LOT PRODUCTION, NO THIS NONCONFORMITY RECORD . THIS EVENT WAS SINGLE CASE. THIS PRODUCTION WAS IN USE FOR 3 YEARS, FROM EVALUATION ,THE CASTER LACK OF INSPECTION AND ADJUSTMENT. AS SPECIFIED IN THE USER MANUAL P27, ADJUST FRONT CASTERS / FORKS BEARING SYSTEM IF WHEEL BOBBLES NOTICEABLY OR BINDS TO A STOP . END USER SHOULD READ USER MANUAL BEFORE USING THIS PRODUCTION ,SAFETY INSPECTION AND ADJUSTMENT SHOULD BE PERFORMED ACCORDING TO USER MANUAL.

    Description of Event or Problem · 1

    DEALER ALLEGES THE RIGHT REAR WHEEL CAME OFF THE CHAIR AND THE PATIENT ALLEGEDLY FELL OUT OF THE CHAIR AND WAS INJURED. DEALER STATES THE PATIENT ALLEGEDLY SUSTAINED A PELVIC FRACTURE WHEN SHE FELL OUT OF THE CHAIR. SHE ALLEGEDLY REQUIRED HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668744 TRSX5/WD86/ADULT/28FB/BH16/1255/U2222C/COM/U240 9153637785 MECHANICAL WHEELCHAIR IOR DANYANG JUMAO HEALTHCARE EQUIPMENT CO.,LTD. TRSX58FB

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Hospitalization