BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGT NASAL PREFORMED ENDOTRACHEAL TUBE

    MDR report key: 225910 · Received June 2, 1999

    Report

    Report Number
    48207-1999-00048
    Event Type
    Injury
    Date Received
    June 2, 1999
    Report Date
    June 2, 1999
    Manufacturer
    WILLY RUSCH, AG
    Product Code
    BTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT IS ALLEGED THAT THE NURSE ATTEMPTED TO INTUBATE THE PT, BUT WAS UNSUCCESSFUL, AS THE BALLOON WAS ALLEGEDLY TORN DURING INTUBATION. THE NURSE ATTEMPTED TO INTUBATE THE PT AGAIN, AND WAS AGAIN UNSUCCESSFUL. IT WAS NOTED THAT DURING THE SECOND INTUBATION THE PT BECAME SWOLLEN. A THIRD INTUBATION WAS NOT POSSIBLE AND THE PT WAS TRANSPORTED TO THE HOSP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AGT NASAL PREFORMED ENDOTRACHEAL TUBE NASAL ENDOTRACHEAL TUBE BTR WILLY RUSCH, AG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| R