BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEPARIN 10UNITS/ML

    MDR report key: 1021516 · Received March 27, 2008

    Report

    Report Number
    MW5006051
    Event Type
    Injury
    Date Received
    March 27, 2008
    Date of Event
    March 24, 2008
    Report Date
    March 27, 2008
    Manufacturer
    MEDEFIL
    Product Code
    NZW
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    EXPERIENCED HIVES OVER BODY ATTRIBUTED TO HEPARIN FLUSH FOR CENTRAL LINE. HEPARIN WAS FROM AFFECTED LOTS RECALLED BY MFR THAT WERE DETERMINED TO CAUSE ALLERGIC REACTIONS. DOSE, FREQUENCY & ROUTE USED: 3ML IV, THERAPY DATES: 2008. DIAGNOSIS FOR USE: PORT CARE. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED. YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEPARIN 10UNITS/ML NONE NZW MEDEFIL H07325

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Required Intervention