BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 2940331 · Received February 2, 2013

    Report

    Report Number
    1531186-2013-00391
    Date Received
    February 2, 2013
    Report Date
    February 2, 2013
    Manufacturer
    UNKNOWN
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    (B)(4) - THE DEALER REPORTED THAT THE 65650 ROLLATOR CHAIR CRACKED UPON THE UNDER WEIGHT LIMIT END USER SAT ON IT. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45826 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ UNKNOWN 65650

    Patients

    Seq Age Sex Outcome Treatment
    1 Other