BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 3103280 · Received May 9, 2013

    Report

    Report Number
    1531186-2013-01969
    Date Received
    May 9, 2013
    Report Date
    April 12, 2013
    Manufacturer
    GENTEEL HOMECARE PRODUCTS
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    ON ORIGINAL ORDER (B)(4) SEAT CRACK - JUST RECEIVED SEAT IN AND IT BROKE,THEN (B)(4) REPLACEMENT CRACK ALSO - 65100 ROLLATOR USER HAS HAD ABOUT 4 YEARS-USER SAT PLASTIC SEAT NOT SAME AS HIS ORIGINAL SEAT - WILL RETURN IF 3RD HAS TO BE SENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203468 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ GENTEEL HOMECARE PRODUCTS 65100

    Patients

    Seq Age Sex Outcome Treatment
    1 Other