BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 2853655 · Received December 3, 2012

    Report

    Report Number
    1531186-2012-01563
    Date Received
    December 3, 2012
    Date of Event
    October 26, 2012
    Report Date
    November 30, 2012
    Manufacturer
    GENTEEL HOMECARE PRODUCTS
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6), IT WAS REPORTED BY THE CONSUMER THAT THE 6300-ATA WALKER COURT SIDE GLIDES WERE NOT MOVING OR ROLLING. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ GENTEEL HOMECARE PRODUCTS 6300-ATA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other