BEUDAMED
    FDA Adverse Event Other Summary report: N

    PK DIEGO 2MM STR AGG TURBINATE

    MDR report key: 2933212 · Received January 15, 2013

    Report

    Report Number
    1037007-2013-00001
    Event Type
    Other
    Date Received
    January 15, 2013
    Report Date
    December 21, 2012
    Manufacturer
    GYRUS AMCI, INC.
    Product Code
    ERL
    PMA / PMN Number
    034004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BLADE INSULATION PEELED AND BROKE INTO TWO PIECES WHILE IN THE PT'S NOSE. THE PLASTIC COATING AND BLADE WAS RETRIEVED WITHOUT ANY PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22979 PK DIEGO 2MM STR AGG TURBINATE ERL GYRUS AMCI, INC. IH492904

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention