BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7.5 ANTERIOR/POSTERIOR

    MDR report key: 950997 · Received April 19, 2007

    Report

    Report Number
    3004063246-2007-00001
    Event Type
    Malfunction
    Date Received
    April 19, 2007
    Date of Event
    March 20, 2007
    Report Date
    March 20, 2007
    Manufacturer
    ARTHROCARE UK LTD
    Product Code
    EMX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    IN 2007, A CLINICAL INCIDENT INVOLVING A RAPID RHINO DEVICE WAS REPORTED TO ARTHROCARE CORP. THE NEXT DAY, A RAPID RHINO NASAL CATHETER WAS PLACE IN EACH OF THE PATIENT'S NASAL PASSAGES TO ALLEVIATE NASAL BLEEDING. THE PT WAS OBSERVED OVERNIGHT. ON THE EVENT DATE, ONE OF THE TWO RAPID RHINO DEVICES DISASSEMBLED AND THE INTERIOR PORTION ASPIRATED INTO THE AIRWAY OF THE PT. THE DETACHED DEVICE WAS REMOVED BY THE PHYSICIAN FROM THE PATIENTS'S AIRWAY. THE SECOND DEVICE PLACED IN THE OPPOSITE NASAL PASSAGE REMAINED IN PLACE. NO REPORTED PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7.5 ANTERIOR/POSTERIOR EPISTAXIS BALLOON EMX ARTHROCARE UK LTD NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other