BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN PREFILL

    MDR report key: 1183363 · Received October 1, 2008

    Report

    Report Number
    3002859087-2008-00049
    Event Type
    Malfunction
    Date Received
    October 1, 2008
    Report Date
    September 26, 2008
    Manufacturer
    COVIDIEN
    Product Code
    NZW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ROGER DRAKE OF BAUM, HEDLUND, ARISTEI AND GOLDMAN ALLEGES IN A CIVIL COMPLAINT THAT HIS CLIENT WAS INJURED AS A RESULT OF EXPOSURE TO HEPARIN. NO SPECIFIC INFORMATION RELATED TO THE EXACT NATURE OF THE CLIENT'S INJURY WAS PROVIDED AND NO SPECIFIC INFORMATION RELATED TO THE ACTUAL MANUFACTURER OF HEPARIN INVOLVED WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK