BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 4120337 · Received September 26, 2014

    Report

    Report Number
    1525712-2014-06332
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Report Date
    August 15, 2014
    Manufacturer
    UNKNOWN
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN END USER'S DAUGHTER CALLED HIM AND REPORTED THAT SOMETHING NEAR THE SEAT OF THE ROLLATOR IS CRACKED CAUSING HER DRESS TO GET CAUGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601690 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other