BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINCKRODT

    MDR report key: 673489 · Received February 1, 2006

    Report

    Report Number
    673489
    Event Type
    Injury
    Date Received
    February 1, 2006
    Date of Event
    January 26, 2006
    Report Date
    January 30, 2006
    Manufacturer
    MMJS. ADE C.V.
    Product Code
    BSR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT. INTUBATED FOLLOWING BIRTH. PLACEMENT 4-RY REVEALED TIP OF PLASTIC SHEATH ON INTUBATION STYLET, APPROX. 2 IN. REQUIRED BRONCHOSCOPY FOR REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALLINCKRODT INTUBATION STYLET SIZE 6FR. BSR MMJS. ADE C.V. * 0511002159
    2 * * --- * * *
    3 * * --- * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DAY Life Threatening| R