BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAPID RHINO EPISTAXIS DEVICE

    MDR report key: 2223838 · Received August 18, 2011

    Report

    Report Number
    2951580-2011-00125
    Event Type
    Injury
    Date Received
    August 18, 2011
    Date of Event
    January 1, 2011
    Report Date
    August 5, 2011
    Manufacturer
    ARTHROCARE CORP.
    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

    Additional Manufacturer Narrative · 1

    THE PATIENT'S AGE AND GENDER HAVE BEEN REQUESTED BUT NOT RECEIVED. ADDITIONALLY, NO CATALOG OR LOT NUMBER WAS PROVIDED; THEREFORE, NO MANUFACTURING OR EXPIRATION DATE COULD BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN UNSPECIFIED EPISTAXIS AND WAS TREATED WITH A RAPID RHINO EPISTAXIS DEVICE. AFTER INSERTION, THE PATIENT REPORTEDLY BEGAN GAGGING AND REBLEEDING. UPON EXAMINATION, IT WAS FOUND THAT THE LEFT NASAL PACK HAD BECOME DISPLACED. ATTEMPTS TO FOLLOW UP ON THE PATIENT'S SUBSEQUENT TREATMENT AND CONDITION WERE UNSUCCESSFUL. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAPID RHINO EPISTAXIS DEVICE NASAL BALLOON EMX ARTHROCARE CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention