BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 3073579 · Received April 23, 2013

    Report

    Report Number
    1531186-2013-01720
    Date Received
    April 23, 2013
    Report Date
    March 28, 2013
    Manufacturer
    UNKNOWN
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    POTENTIAL FOR INJURY ASSOCIATED WITH A 65650 ROLLATOR WITH A BROKEN CASTER. THIS EVVENT COULD RESSULT IN INCONSISTENT OPERATION OF THE UNIT WHICH COULD RESULT IN INJURY TO THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175348 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ UNKNOWN 65650

    Patients

    Seq Age Sex Outcome Treatment
    1 Other