BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 2771529 · Received October 4, 2012

    Report

    Report Number
    9616091-2012-00299
    Date Received
    October 4, 2012
    Report Date
    August 29, 2012
    Manufacturer
    CONSMA
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) CDRH'S EMDR SYSTEM ENCOUNTERED A PROCESSING ISSUE THAT PREVENTED THE SUCCESSFUL TRANSMISSION OF INVACARE'S ELECTRONIC SUBMISSIONS. THEREFORE, THE REPORTING FIRM WAS IN COMPLIANCE WITH CFR 803.

    Description of Event or Problem · 1

    "PER DEALER THE SEAT ON THE ROLLATOR BROKE IN HALF. SHIPPED NEW SEAT TO HIM UNDER WARRANTY #(B)(4)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ CONSMA 65650R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other