BEUDAMED
    FDA Adverse Event Other Summary report: N

    EASYCAP II

    MDR report key: 2483150 · Received March 2, 2012

    Report

    Report Number
    2936999-2012-00081
    Event Type
    Other
    Date Received
    March 2, 2012
    Date of Event
    February 1, 2012
    Report Date
    February 6, 2012
    Manufacturer
    COVIDIEN, FORMERLY TYCO
    Product Code
    CCK
    PMA / PMN Number
    K944400
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT RETURNED FOR EVAL. THE LOT NUMBER WAS NOT PROVIDED SO MFR DATE IS UNK. THE CUSTOMER HAS NOT RESPONDED TO OUR INQUIRIES FOR FURTHER INFO. THE MFR OF THE CALCIUM OXIDE PACKET - SUD-SHEMI - STATES PACKET WILL GENERATE HEAT ON CONTACT WITH H2O OR MOISTURE. THIS RISK IS INDICATED ON THE PACKAGING.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN THAT THE CALCIUM OXIDE PACKAGE THAT SHIPS WITH THE EASYCAP II GOT WET AND THE PT RECEIVED A BURN ON THE ARM. NO OTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYCAP II CO2 DETECTOR CCK COVIDIEN, FORMERLY TYCO

    Patients

    Seq Age Sex Outcome Treatment
    1 Other