BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 2912603 · Received January 13, 2013

    Report

    Report Number
    1531186-2013-00188
    Date Received
    January 13, 2013
    Date of Event
    December 12, 2012
    Report Date
    January 13, 2013
    Manufacturer
    GENTEEL HOMECARE PRODUCTS
    Product Code
    ITJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) - THE DEALER REPORTED THAT THE 6291-JR WALKER WAS DAMAGED BY THE PATIENT FALLING OVER IT, ALLEGEDLY DUE TO SUFFERING A HEART INFARCTION OR A STROKE. THERE WAS NO ALLEGATION OF PRODUCT MALFUNCTION, OR THAT IT HAD LIKELY CAUSED OR CONTRIBUTED TO THE INCIDENT, WHICH WAS PROBABLY CONSEQUENT OF THE END USER POOR HEALTH CONDITION. NO OTHER INFORMATION WAS AVAILABLE. ALTHOUGH THIS EVENT HAS NOT BEEN A RESULT OF ALLEGED PRODUCT MALFUNCTION, WE WILL REPORT IT DUE TO LIMITED AVAILABLE INFORMATION. SHOULD WE RECEIVE ADDITIONAL INFORMATION REGARDING THE EVENT, THIS FILE WILL BE REVISED, AND REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19629 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ GENTEEL HOMECARE PRODUCTS 6291-JR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other