BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2862669 · Received December 10, 2012

    Report

    Report Number
    1525712-2012-02774
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Report Date
    December 7, 2012
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RMA HAS BEEN INITIATED FOR THIS ISSUE. THE MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    (B)(4) - NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. PROVIDER, (B)(6) STATES A COUPLE OF YEARS AGO USER WAS GOING OVER A BUMP THE BOTTOM OF HER FOOTPLATE HIT IT AND ALLEGEDLY FEEL OUT IN THE FRONT OF THE CHAIR AFTER IT TIPPED BREAKING BOTH HER LEGS. PROVIDER WAS NOT SURE OF THE ACTUAL DATE OF INCIDENT - COULD HAVE BEEN A FEW WEEKS AGO OR A FEW YEARS AGO AS END USER MENTIONED INJURY IN PASSING. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET TDX5

    Patients

    Seq Age Sex Outcome Treatment
    1 47 Other