BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 3020252 · Received March 25, 2013

    Report

    Report Number
    1531186-2013-01279
    Date Received
    March 25, 2013
    Report Date
    February 28, 2013
    Manufacturer
    UNKNOWN
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    (B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. PROVIDER ALLEGES THE ROLLATOR WAS IN THEIR STORE AND A CUSTOMER SAT ON THIS ROLLATOR AND THE SEAT CRACKED. PROVIDER ALLEGES THE CRACK IS INSIDE AND THE SEAT IS DIPPING DOWN IN THE MIDDLE. PROVIDER ALSO ALLEGES THE CUSTOMER WHO SAT ON THE SEAT WAS UNDER THE MAXIMUM WEIGHT CAPACITY. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122092 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ UNKNOWN 65650

    Patients

    Seq Age Sex Outcome Treatment
    1 Other