BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TARRY MANUFACTURING

    MDR report key: 1488116 · Received September 24, 2009

    Report

    Report Number
    MW5012864
    Event Type
    Injury
    Date Received
    September 24, 2009
    Date of Event
    September 16, 2009
    Report Date
    September 24, 2009
    Manufacturer
    TARRY MANUFACTURING
    Product Code
    FRP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING USE OF POSITIONING AID IN THE NICU, INFANT WAS NOTED WHEN TURNING HEAD THAT HOOD ON BUNTING OBSTRUCTED AIRWAY. HIGH RISK TO INFANT WHEN USED IN THE HOSPITAL SETTING AND EVEN GREATER RISK WHEN INFANT IS IN THE HOME, AND IS NOT BEING MONITORED. WILL ALSO FAX REPORT WITH COPY OF PHOTO DEMONSTRATING AIRWAY OBSTRUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TARRY MANUFACTURING TARRY MANUFACTURING DEVELOPMENTAL POSITIONING AID FRP TARRY MANUFACTURING T901
    2 TARRY MFG TARRY MANUFACTURING DEVELOPMENTAL POSITIONING AID FRP TARRY MANUFACTURING T902
    3 TARRY MANUFACTURING TARRY MANUFACTURING DEVELOPMENTAL POSITIONING AID FRP TARRY MANUFACTURING T903
    4 TARRY MANUFACTURING TARRY MANUFACTURING DEVELOPMENTAL POSITIONING AID FRP TARRY MANUFACTURING T904
    5 TARRY MANUFACTURING TARRY MANUFACTURING DEVELOPMENTAL POSITIONING AID FRP TARRY MANUFACTURING T905

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention