BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICON 25 HCG 8120217

    MDR report key: 1410875 · Received June 26, 2009

    Report

    Report Number
    MW5011778
    Event Type
    Injury
    Date Received
    June 26, 2009
    Date of Event
    May 14, 2009
    Report Date
    June 26, 2009
    Manufacturer
    BECKMAN COULTER
    Product Code
    JHI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD NEGATIVE URINE PREGNANCY TEST IN 2009. PT HAD IUD INSERTED SAME DAY. THE FOLLOWING MONTH, PT SAW PCP WITH NAUSEA, VOMITING, AND VAGINAL BLEEDING. URINE HCG POSITIVE, AND SERUM HCG POSITIVE. TWO DAYS LATER, ULTRASOUND SHOWED INTRAUTERINE PREGNANCY WITH CARDIAC ACTIVITY. PREGNANCY NOW COMPLICATED BY IUD. PRACTICE MANAGER OF PHYSICIAN OFFICE REPORTED PROBLEM TO MANUFACTURER. DATES OF USE: 2009. DIAGNOSIS: PREGNANCY TEST - URINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICON 25 HCG 8120217 NONE JHI BECKMAN COULTER 43025

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other