BEUDAMED
    FDA Adverse Event Summary report: N

    IVEDCO

    MDR report key: 597035 · Received April 19, 2005

    Report

    Report Number
    MW4003918
    Date Received
    April 19, 2005
    Date of Event
    April 1, 2004
    Report Date
    March 9, 2005
    Manufacturer
    IVEDCO
    Product Code
    FMF
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HAD A COMPOUND FRACTURE OF LEG. WHILE IN THE HOSPITAL, HAD LINE PUT IN CHEST AREA. DEVELOPED INFECTION BEFORE LINE WAS PUT IN. WENT HOME AND WAS SHOWN HOW TO USE IV FLUSH SYRINGES. ORDERED THEM FROM IVEDCO, MAIL ORDER. GOT VERY SICK, WENT TO DOCTOR, THEY WANTED TO AMPUTATE LEG AS INFECTION WAS OUT OF CONTROL. HAS SINCE BEEN PUT ON ORAL MEDS BUT STILL FEELS THEY HAVE INFECTION IN LEG. PT WAS ON IV VANCOMYCIN, 3 TIMES DAILY, FOR 4 MONTHS. ONCE STARTED USING IVEDCO PRODUCT, WITHIN 3-5 MINUTES, SUFFERED SEVERE CHILLS AND THEN WOULD RUN A FEVER. STARTED FEELING BETTER 2-3 DAYS AFTER STOPPED USING THE IVEDCO PRODUCT. RX LABEL OF IVEDCO ON PLASTIC BAG. SYRINGES LABELED BY IV FLUSH HEPARIN 10U/ML 5 ML/10ML SYRINGE AND LABEL ROUND LENGTHWISE, SINGLE USE ONLY, PERSERVATIVE FREE IV FLUSH, DALLAS TX. EXPIRATION DATE ON RX LABEL ON BAG READS 110904 BUT ON SYRINGES READS 092604.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IVEDCO HEPARIN LOCK FLUSH SYRINGES FMF IVEDCO * 032604

    Patients

    Seq Age Sex Outcome Treatment
    1 *