BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAPID RHINO 752 EPISTAXIS DEVICE

    MDR report key: 2223834 · Received August 18, 2011

    Report

    Report Number
    2951580-2011-00117
    Event Type
    Injury
    Date Received
    August 18, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 1, 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
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT'S AGE AND GENDER HAVE BEEN REQUESTED BUT NOT RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN ADMINISTERED POST-OPERATIVELY A RHINO 752 EPISTAXIS DEVICE (OFF-LABEL) FOR THE TREATMENT/PREVENTION OF EPISTAXIS. AFTER INSERTION, THE PATIENT REPORTED DIFFICULTY SWALLOWING. UPON EXAMINATION, IT WAS FOUND, THE NASAL PACK HAD SLIPPED DOWN THE PATIENT'S THROAT. 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 752 EPISTAXIS DEVICE BALLOON, EPISTAXIS EMX ARTHROCARE CORP. FZ14800-A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention