BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2892021 · Received January 1, 2013

    Report

    Report Number
    1525712-2012-03428
    Event Type
    Malfunction
    Date Received
    January 1, 2013
    Report Date
    December 31, 2012
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    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). NO 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. CUSTOMER STATED THEY RAN INTO A MUD HOLE AND BENT THE LOWER PIVOT LINK. MDR FILED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other