BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEPARIN 1,000 U

    MDR report key: 990681 · Received January 30, 2008

    Report

    Report Number
    MW5005173
    Event Type
    Injury
    Date Received
    January 30, 2008
    Date of Event
    January 3, 2008
    Report Date
    January 30, 2008
    Manufacturer
    BAXTER
    Product Code
    NZW
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DIALYSIS CIRCUIT FLUSHED WITH HEPARIN 1,000 U PRIOR TO DIALYSIS TREATMENT START. WHEN TREATMENT STARTED, COMPLAINED OF NAUSEA, THROAT SWELLING, COULD NOT OPEN MOUTH, AUDIBLE RHONCHI WHEN BREATHING. DIALYSIS CEASED, DIALYZER DISCARDED. REGLAN 5 MG AND BENADRYL 50 MG GIVE IV. TRANSFERRED TO ER, THEN ADMITTED TO HOSPITAL OVERNIGHT. RECEIVED MEDICAL NEBULIZER TREATMENTS X 3, SOLU MEDROL 125 MG IV X 2, PEPCID 20 MG IV, AND BENADRYL 25 MG PO Q 6 HOURS - WITH A RX FOR BENADRYL 50 MG P.O. DAILY X 5 DAYS ON DISCHARGE-. OBSERVED, VS STABLE. DISCHARGED AT 1525 WITH NO FURTHER COMPLAINTS. TWO LOT NUMBERS OF RECENTLY RECALLED BAXTER. HEPARIN 1,000 U IN STOCK AT THIS TIME. LOT# 047056 IN STOCK SINCE 09/18/2007, AND LOT# 107024 IN STOCK SINCE 10/09/2007. DATES OF USE: 2007 - 2008. DIAGNOSIS OR REASON FOR USE: DIALYSIS. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEPARIN 1,000 U NONE NZW BAXTER 047056
    2 HEPARIN 1,000 U NONE NZW BAXTER 107024

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| L| S