BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SATIN SLIP

    MDR report key: 5317948 · Received September 29, 2004

    Report

    Report Number
    2936999-2004-00033
    Event Type
    Malfunction
    Date Received
    September 29, 2004
    Report Date
    September 29, 2004
    Manufacturer
    RESPIRATORY
    Product Code
    FSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOSPITAL HAS NOT RETURNED THIS DEVICE TO NELLCOR AND THEREFORE EVAL IS NOT POSSIBLE AT THIS TIME. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL OR CORRECTED REPORT WILL BE PROVIDED TO THE FDA FOLLOWING COMPLETION OF THE EVAL.

    Description of Event or Problem · 1

    DURING A DIAPER CHANGE, THE INFANT COUGHED AND THE ATTENDING RN NOTED SMALL TUBE IN PATIENT'S THROAT. TUBE REMOVED BY OTOLARYNGOLOGIST. PATIENT HAS SINCE BEEN DISCHARGED FROM HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SATIN SLIP INTUBATION STYLET STERILE FSQ RESPIRATORY

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention