BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2951022 · Received February 8, 2013

    Report

    Report Number
    1525712-2013-00974
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 10, 2013
    Report Date
    February 8, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    (B)(4). INJURY ALLEGED. MALFUNCTION ALLEGED. PER DEALER, THE CONSUMER TRIED TO TURN QUICKLY TO GET OUT OF THE WAY OF A CAR AND THE FRONT CASTER WAS CAUGHT IN A GRATE. SHE WAS NOT WEARING HER SEATBELT AT THE TIME. THE PARAMEDICS AND FIRE DEPARTMENT WERE CALLED. SHE RECEIVED ABRASIONS TO HER RIGHT ARM AND BACK. SHE IS COMPLAINING OF A BAD HEADACHE AND GENERAL SORENESS. THE CHAIR HAS SIGNIFICANT DAMAGE. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54814 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET TDXSP-CG

    Patients

    Seq Age Sex Outcome Treatment
    1 42 Hospitalization