BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRODUCT CODE 901012 PARA-PAK ZN-PVA

    MDR report key: 543334 · Received September 9, 2004

    Report

    Report Number
    1524213-2004-00001
    Event Type
    Other
    Date Received
    September 9, 2004
    Date of Event
    August 5, 2004
    Report Date
    September 9, 2004
    Manufacturer
    MERIDIAN BIOSCIENCE, INC.
    Product Code
    LDX
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    MERIDIAN BIOSCIENCE, WAS CONTACTED ABOUT A HOSPITALIZED PT. WHILE IN THE HOSPITAL, THE PT WAS GIVEN ONE 15ML VIAL OF THE STOOL TRANSPORT MEDIUM PARA-PAK ZN-PVA IN ORDER TO COLLECT STOOL. THE PT INSTEAD DRANK PART OR ALL OF THE CONTENTS OF THE VIAL. AFTER DRINKING THE CONTENTS THEY VOMITTED GREEN BILE AND MUCOUS. THEY WERE GIVEN MILK OF MAGNESIA BY THE HOSP STAFF. AFTER VOMITING THE PT WAS ASYMPTOMATIC AND ABLE TO CONSUME FOOD AND LIQUIDS. INCIDENT OCCURRED AT APPROX 10:30PM IN 2004. IT WAS REPORTED TO THE POISON CONTROL CENTER AT 8:00AM ON THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRODUCT CODE 901012 PARA-PAK ZN-PVA STOOL COLLECTION, PRESERVATION & COLLECTION DEVICE LDX MERIDIAN BIOSCIENCE, INC. NA 731330

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other