BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEPATITIS C SEROCONVERSION PANEL (PHV901)

    MDR report key: 800556 · Received December 27, 2006

    Report

    Report Number
    1220394-2006-00003
    Event Type
    Other
    Date Received
    December 27, 2006
    Date of Event
    December 10, 2006
    Report Date
    December 27, 2006
    Manufacturer
    BBI DIAGNOSTICS
    Product Code
    MZP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE PRODUCT WAS TRANSFERRED FROM THE ORIGINAL PACKAGING, NO ATTEMPT WAS MADE FOR RETURN OF THE PRODUCT. THE PRODUCT LABELING INCLUDES A SAFETY PRECAUTION STATMENT TO USE UNIVERSAL PRECAUTIONS WHEN HANDLING THE PRODUCT.

    Description of Event or Problem · 1

    TECHNOLOGIST REPORTED EYE SPLASH WITH PRODUCT. HE TRANSFERRED PRODUCT TO A DIFFERENT CONTAINER. UPON CLOSING THE CAP OF THAT CONTAINER, ONE DROP OF PRODUCT NEAR THE CAP SPLASHED IN HIS LEFT EYE. TECHNOLOGIST WAS NOT WEARING PROTECTIVE EYEWEAR. HE FLUSHED HIS EYE WITH WATER FOR APPROXIMATELY 30 SECONDS. AS THE PRODUCT CONTAINS HEPATITIS C POSITIVE RAW MATERIAL, TECHNOLOGIST CONSULTED WITH AN INFECTIOUS DISEASE SPECIALIST AND WAS TOLD THE RISK OF INFECTION WAS LOW, TESTED LIVER ENZYME (ALT) AND WAS ADVISED TO REPEAT THE LIVER ENZYME TEST AFTER 3 MONTHS AND HCV ANTIBODY TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEPATITIS C SEROCONVERSION PANEL (PHV901) HEPATITIS C SEROCONVERSION PANEL MZP BBI DIAGNOSTICS PHV901 110923

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other