BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 2912428 · Received January 12, 2013

    Report

    Report Number
    1531186-2013-00173
    Date Received
    January 12, 2013
    Report Date
    January 12, 2013
    Manufacturer
    SHUNLONG PHYSICAL THERAPY EQUIPMENT
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    MDR DECISION DATE: (B)(6). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. DEALER STATED THAT THE RUBBER LINING ON THE WHEEL IS COMING OFF. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19408 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ SHUNLONG PHYSICAL THERAPY EQUIPMENT 65550

    Patients

    Seq Age Sex Outcome Treatment
    1 29 Other