BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRODUCT CODE 901012 PARA-PAK ZN-PVA

    MDR report key: 5310273 · Received September 10, 2004

    Report

    Report Number
    1524213-2004-00002
    Event Type
    Other
    Date Received
    September 10, 2004
    Date of Event
    August 10, 2004
    Report Date
    September 10, 2004
    Manufacturer
    MERIDIAN BIOSCIENCE, INC.
    Product Code
    JSM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    0

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT IS INTENDED FOR USE IN PHYSICIAN OFFICES AND LABORATORIES. IT IS LABELED WITH WARNING SYMBOLS AND IN ENGLISH TO INDICATE THAT IT IS HARMFUL IF SWALLOWED. THE DIRECTION CIRCULAR PROVIDED WITH THE PRODUCT CONTAINS HARMFUL WARNINGS IN 5 LANGUAGES. THIS IS AN IN VITRO DIAGNOSTIC DEVICE AND NOT INTENDED TO BE SWALLOWED.

    Description of Event or Problem · 1

    ON 08/10/2004 THE (B)(6) CENTER IN (B)(6) NOTIFIED MERIDIAN THAT A (B)(6) MALE DRANK ZN-PVA, A PARA-PAK STOOL PRESERVATION DEVICE. THE PT WAS ADMITTED TO THE HOSPITAL COMPLAINING OF STOMACH PAINS. HE WAS LATER DISCHARGED WITHOUT INCIDENT. THE PT WAS TRANSFERRED TO A PSYCHIATRIC HOSPITAL FOR OBSERVATION. THE ATTENDING PHYSICIAN DETERMINED THAT THE INGESTION WAS INTENTIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRODUCT CODE 901012 PARA-PAK ZN-PVA PARA-PAK STOOOL COLLECTION, PRESERVATION, TRANSPORT DEVICE JSM MERIDIAN BIOSCIENCE, INC. NA NOT KNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Other