BEUDAMED
    FDA Adverse Event Other Summary report: N

    TAILWIND

    MDR report key: 1491805 · Received October 1, 2009

    Report

    Report Number
    3002877294-2009-00002
    Event Type
    Other
    Date Received
    October 1, 2009
    Date of Event
    September 1, 2009
    Report Date
    September 4, 2009
    Manufacturer
    CREATIVE TECHNOLOGY SERVICES
    Product Code
    ITI
    PMA / PMN Number
    K022704
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INJURY REPORTED BY THE END USER DID NOT RESULT IN THE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE. THE END USER ALLEGES THAT HE SUSTAINED A BRUISE AND A FRACTURED RIB FROM CONTACT WITH THE PUSH HANDLES. THE END USER DID NOT INDICATE THAT HE SOUGHT MEDICAL ATTENTION OR A MEDICAL DIAGNOSIS OF THE FRACTURED RIB. ALL SEATBACKS AND HANDLES ARE ASSEMBLED ACCORDING TO THE CUSTOMER SPECIFICATIONS AND DIMENSIONS.

    Description of Event or Problem · 1

    THE DEALER, ON BEHALF OF THE END USER, FORWARDED AN E-MAIL HE HAD RECEIVED FROM THE END USER. THE END USER ALLEGES THAT THE DESIGN OF THE BACK OF THE CHAIR CONTRIBUTED TO HIS INJURY. END USER'S E-MAIL, STATES THAT THE "TWO POLES STICKING OUT FROM THE TOP" OF THE DEVICE, CAUSED BRUISING AND A RIB FRACTURE. THE END USER ALLEGES THAT THE DESIGN OF THE BACK OF THE CHAIR CONTRIBUTED TO HIS INJURY. THE END USER DID NOT REPORT THAT HE REQUIRED MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAILWIND WHEELCHAIR, POWERED ITI CREATIVE TECHNOLOGY SERVICES TAILWIND NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other