BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 3203391 · Received July 2, 2013

    Report

    Report Number
    1531186-2013-02910
    Date Received
    July 2, 2013
    Report Date
    June 10, 2013
    Manufacturer
    SHUNLONG PHYSICAL THERAPY EQUIPMENT
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MANUFACTURER IS (B)(4).

    Description of Event or Problem · 1

    PROVIDER STATES THE MIDDLE SCREW ON THE HAND BRAKE HAS FALLEN OUT. NO INDIVIDUAL PARTS TO SEND OUT. HAVE TO SEND OUT THE WHOLE BRAKE ASSEMBLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301136 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ SHUNLONG PHYSICAL THERAPY EQUIPMENT 65550

    Patients

    Seq Age Sex Outcome Treatment
    1 Other