BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNK PREFILL

    MDR report key: 1851016 · Received September 29, 2010

    Report

    Report Number
    3002859087-2010-00151
    Event Type
    Death
    Date Received
    September 29, 2010
    Date of Event
    May 1, 2008
    Report Date
    September 20, 2010
    Manufacturer
    COVIDIEN
    Product Code
    NZW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    ON 09/20/10, COVIDIEN WAS INFORMED OF A CUSTOMER WHO HAD AN ISSUE WITH A HEPARIN PREFILLED SYRINGE. THE ATTORNEY ALLEGES THAT IN (B)(6) 2008, THE PT WAS ADMINISTERED HEPARIN WHILE AT A HOSPITAL, AND EXPERIENCED, AMONG OTHER SYMPTOMS, ORGAN FAILURE , HEART PROBLEMS, INCREASED SWEATING, CHEST PAIN, ABDOMINAL PAIN, THROAT SWELLING, FAINTING, SKIN REDNESS, AND LOW ENERGY. UPON INFO AND BELIEF, ON AT LEAST ONE OCCASION, THE HEPARIN ADMINISTERED TO THE PT WAS ALLEGED TO BE CONTAMINATED HEPARIN. SHORTLY THEREAFTER, THE PT BEGAN TO EXPERIENCE ADVERSE REACTIONS CONSISTENT WITH THE ADVERSE REACTIONS ASSOCIATED WITH CONTAMINATED HEPARIN. THE PT PASSED ON (B)(6)2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK PREFILL HEPARIN PREFILL NZW COVIDIEN UNK PREFILL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death