BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDEFIL

    MDR report key: 1052153 · Received May 23, 2008

    Report

    Report Number
    MW5007031
    Event Type
    Injury
    Date Received
    May 23, 2008
    Date of Event
    March 28, 2008
    Report Date
    May 23, 2008
    Manufacturer
    MEDEFIL
    Product Code
    NZW
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NOTIFIED 5/21/08 OF PATIENT. MOTHER STILL HAS SUPPLY OF RECALLED HEPARIN AT HOME. FAMILY/PHYSICIAN CONCERN IF RECENT HOSPITALIZATION COULD BE RELATED TO HEPARIN DOSING? HEPARIN 500 UNITS GIVEN PRNC HOME FOR LINE PATENCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDEFIL HEPARIN FLUSH 100U/CC NZW MEDEFIL H107301 35
    2 MEDEFIL HEPARIN FLUSH 100U/CC NZW MEDEFIL H107309-60
    3 MEDEFIL HEPARIN FLUSH 100U/CC NZW MEDEFIL H106366 2

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Hospitalization