BEUDAMED
    FDA Adverse Event Summary report: N

    *

    MDR report key: 285559 · Received July 11, 2000

    Report

    Report Number
    MW1019268
    Date Received
    July 11, 2000
    Date of Event
    June 19, 2000
    Manufacturer
    BIOSTAR, INC.
    Product Code
    JHJ
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PT TO CLINIC FOR DEPO SHOT HAD POSITIVE PREGNANCY TEST, WAS ON MENSES AT THAT TIME. SENT TO PRIVATE MEDICAL DR FOR BLOOD HCG. RETURNED TO CLINIC 2000 WITH RESULTS OF BLOOD HCG (NEG). SUSPECTED PROBLEM WITH PREGNANCY TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * ACCEAVA HCG URINE TEST JHJ BIOSTAR, INC. * 017304

    Patients

    Seq Age Sex Outcome Treatment
    1 *