BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAPID RHINO 5.5 CM

    MDR report key: 516925 · Received March 11, 2004

    Report

    Report Number
    MW1031499
    Event Type
    Injury
    Date Received
    March 11, 2004
    Date of Event
    March 4, 2004
    Report Date
    March 11, 2004
    Manufacturer
    APPLIED THERAPEUTICS, BHK HOLDING
    Product Code
    EMX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RAPID RHINO AFTER SEPTOPLASTY/TURBINATE REDUCTION WAS INFLATED BY THE SURGEON-BECAME DETACHED FROM THE NASAL TAMPON AT THE JUNCTURE OF INSUFFLATION TUBING AND BASE OF THE TAMPON. THE PRODUCT WAS REMOVED FROM THE NARES AND THE STERILE FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAPID RHINO 5.5 CM BILATERAL NASAL INFLATABLE NASAL TAMPON EMX APPLIED THERAPEUTICS, BHK HOLDING 0297 2003-01-02

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention