BEUDAMED
    FDA Adverse Event Death Summary report: N

    PEDI-CAP

    MDR report key: 1450049 · Received August 24, 2009

    Report

    Report Number
    2936999-2009-00544
    Event Type
    Death
    Date Received
    August 24, 2009
    Date of Event
    August 19, 2009
    Report Date
    August 20, 2009
    Manufacturer
    COVIDIEN/FORMERLY TYCO HEALTHCARE
    Product Code
    CCK
    Removal / Correction Number
    PENDING
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN IS ATTEMPTING TO OBTAIN MORE INFORMATION ON THE EVENT. MANUFACTURER HAS NOTIFIED FDA OF RECALL ON 8/14/2009.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN IN 2009 THAT THE FACILITY MAY HAVE USED A RECALLED DEVICE DURING AN INFANT CODE. THE PT COULD NOT BE RESUSCITATED. AT THIS TIME THERE IS NO INDICATION ABOUT WHAT IF ANY ROLE THIS DEVICE MAY HAVE PLAYED IN THE EVENT. THE PACKAGING WAS THROWN AWAY. IT IS UNK IF THE PEDI-CAP USED ON THE PT WAS A RECALLED LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEDI-CAP PEDIATRIC C02 DETECTOR CCK COVIDIEN/FORMERLY TYCO HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Death