BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN PREFILL

    MDR report key: 1290683 · Received January 20, 2009

    Report

    Report Number
    3002859087-2009-00001
    Event Type
    Death
    Date Received
    January 20, 2009
    Date of Event
    January 1, 2007
    Report Date
    January 16, 2009
    Manufacturer
    COVIDIEN
    Product Code
    NZW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IN EARLY 2009, COVIDIEN WAS INFORMED OF A CUSTOMER WHO HAD AN ISSUE WITH HEPARIN. THE ATTORNEY ALLEGES THE DECEDENT WAS ADMITTED TO THE HOSPITA IN 2007 FOR WEAKNESS. WHILE HOSPITALIZED, SHE WAS ADMINISTERED HEPARIN AND BEGAN TO HAVE SYMPTOMS CONSISTENT WITH THE HYPERSENSITIVITY TYPE ADVERSE REACTIONS FROM CONTAMINATED HEPARIN REPORTED TO AND BEING INVESTIGATED BY THE FDA AND OTHERS. UPON INFORMATION AND BELIEF ON AT LEAST ONE OCCASION, THE HEPARIN ADMINISTERED TO DECEDENT WAS A CONTAMINATED HEPARIN PRODUCT. THE PATIENT PASSED AWAY THE FOLLOWING MONTH IN LATE 2007.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death