BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 3033899 · Received April 3, 2013

    Report

    Report Number
    1531186-2013-01383
    Date Received
    April 3, 2013
    Report Date
    March 7, 2013
    Manufacturer
    GENTEEL HOMECARE PRODUCTS
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    (B)(4) IT WAS REPORTED BY THE CONSUMER THAT THE 68100-TA ROLLATOR HAD THE REAR BRAKES CABLE FRAYED AND THE TENSION WAS LOOSE, RESULTING IN THE BRAKES NOT LOCKING. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135995 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ GENTEEL HOMECARE PRODUCTS 68100-TA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other