BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3181916 · Received June 21, 2013

    Report

    Report Number
    9615350-2013-00012
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Report Date
    May 23, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - FOLLOW UP #001. INITIAL (B)(4) ISSUED MFR. REPORT # 9615350-2013-00012, INDICTING THE BRAND NAME AS WHEELCHAIR COMPONENTS, THE CORRECT NAME IS POWERED WHEELCHAIR; THE COMMON DEVICE NAME AS 890.3920, THE CORRECT DEVICE IS 890.3860; THE MANUFACTURER AS MOTION CONCEPTS WHEN THE MANUFACTURER IS INVACARE TAYLOR STREET. THE FDA REGISTRATION NUMBER WAS REPORTED AS (B)(4) WHEN IN FACT IT IS (B)(4) FOR INVACARE.

    Description of Event or Problem · 1

    THE DEALER STATES THE METAL RIBBING AROUND THE SHELL OF THE BACK IS COMING OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282037 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET PBR18

    Patients

    Seq Age Sex Outcome Treatment
    1 Other