BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE

    MDR report key: 421542 · Received August 20, 2002

    Report

    Report Number
    MW4003359
    Event Type
    Malfunction
    Date Received
    August 20, 2002
    Report Date
    August 20, 2002
    Manufacturer
    MEDLINE INDUSTRIES INC.
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    COMPLAINANT HAD A TOTAL KNEE REPLACEMENT AND WAS ISSUED A WALKER WHEN THEY LEFT THE HOSP. THEIR FINGERS WERE SMASHED AND PINCHED CLOSING THE WALKER. COMPLAINANT IS ALSO CONCERNED THAT LOOSE CLOTHING COULD GET CAUGHT AND CAUSE A FALL. THE PRODUCT IS MADE IN CHINA AND THE PLASTIC PARTS MAY BE SUBLIMATING AS THERE IS AN ODOR OF MONOMERS. THE CONSTRUCTION IS FLIMSY AND WOULD NOT SUPPORT ANYONE WITH A BODY MASS GREATER THAN 200 POUNDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDLINE WALKER ITJ MEDLINE INDUSTRIES INC. NI J-020163553

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO