BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 2940845 · Received February 4, 2013

    Report

    Report Number
    1531186-2013-00389
    Date Received
    February 4, 2013
    Report Date
    February 2, 2013
    Manufacturer
    GENTEEL HOMECARE PRODUCTS
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    (B)(4) - IT WAS REPORTED BY THE CONSUMER THAT THE 68100-TA ROLLATOR RELEASE BUTTON WAS BROKEN. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47149 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ GENTEEL HOMECARE PRODUCTS 68100-TA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other