BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 3020147 · Received March 25, 2013

    Report

    Report Number
    1531186-2013-01253
    Date Received
    March 25, 2013
    Report Date
    February 26, 2013
    Manufacturer
    GENTEEL HOMECARE PRODUCTS
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    (B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. PROVIDER STATES LEG WELD BROKE CAUSING USER TO FALL. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122239 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ GENTEEL HOMECARE PRODUCTS 68100-TA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other