BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAPID RHINO 550 EPISTAXIS DEVICE

    MDR report key: 2492365 · Received March 13, 2012

    Report

    Report Number
    3006524618-2012-00104
    Event Type
    Injury
    Date Received
    March 13, 2012
    Date of Event
    February 20, 2012
    Report Date
    February 28, 2012
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    EMX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT PRESENTED WITH AN EPISTAXIS REQUIRING URGENT TREATMENT. THE PHYSICIAN REPORTEDLY ATTEMPTED TO TREAT THE PATIENT WITH A RAPID RHINO 550 EPISTAXIS DEVICE; HOWEVER, THE BALLOON DEVICE FAILED TO STAY INFLATED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE MANUFACTURER'S FOLLOW-UP ATTEMPTS ARE UNDERWAY IN ORDER TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAPID RHINO 550 EPISTAXIS DEVICE NASAL, BALLOON EMX ARTHROCARE CORPORATION FV34110-E

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention