BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3902332 · Received June 30, 2014

    Report

    Report Number
    1525712-2014-03243
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 28, 2014
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER STATES ONE CLAMP ON THE BACK OF THE MATRIX BACK IS BROKEN WHERE THE BOLT COMES OUT. BACK NOT LISTED ON ORIGINAL ORDER FOR CHAIR, SO NOT SURE WHICH BACK IT IS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379400 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET 3GTQ-CG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other