BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOT KNOWN

    MDR report key: 812608 · Received January 19, 2007

    Report

    Report Number
    1045254-2007-00001
    Event Type
    Malfunction
    Date Received
    January 19, 2007
    Date of Event
    November 15, 2006
    Report Date
    January 19, 2007
    Manufacturer
    MEDTRONIC ENT
    Product Code
    NLY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT HAS AGREED TO MEET WITH A CO REP IN ORDER TO EVALUATE THE PIECE OF THE DEVICE.

    Description of Event or Problem · 1

    THE PT SENT AN EMAIL TO THE CO WEBSITE STATING THAT IN 2006, SHE STARTED CHOKING AND SPIT OUT THE BROKEN TIP OF A SINUS RESECTOR BLADE THAT WAS EMBEDDED WITHIN A BLOOD CLOT. PT REPORTED NO PHYSICAL INJURY AND INCLUDED A PHOTO OF A FRAGMENT OF WHAT APPEARS TO BE A MEDTRONIC ENT SINUS BLADE. THE PT'S PHYSICIAN AT REGIONAL MED CTR WAS CONTACTED. THE DR STATED THAT DURING THE PT'S SINUS PROCEDURE THIRTEEN DAYS EARLIER, A SINUS BLADE QUIT WORKING AND WAS CHANGED OUT, AND HE CONTINUED WITH THE PROCEDURE. THE PROCEDURE ENDED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOT KNOWN DISPOSABLE SINUS MICRODEBRIDER & RESECTOR BLADE NLY MEDTRONIC ENT NOT KNOWN NOT KNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention