BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 4222993 · Received November 4, 2014

    Report

    Report Number
    1531186-2014-05336
    Date Received
    November 4, 2014
    Report Date
    October 15, 2014
    Manufacturer
    UNKNOWN
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREW THAT GOES INTO THE WHEEL OF THE (B)(4) ROLLATOR IS BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708122 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ UNKNOWN 65650R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other