BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIASORIN LIASON XL HSV 1

    MDR report key: 16753352 · Received April 14, 2023

    Report

    Report Number
    MW5116708
    Event Type
    Injury
    Date Received
    April 14, 2023
    Date of Event
    June 22, 2022
    Report Date
    April 12, 2023
    Manufacturer
    DIASORIN INC.
    Product Code
    MXJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    117
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT HAD A HSV 2 POSITIVE TEST ON THE DIASORIN HSV 1 AND 2 IGG TEST, (INDEX VALUE = 1.27), FOLLOWED UP WITH A WESTERN BLOT WHICH WAS NEGATIVE FOR HSV 2. DATE GIVEN IS THE WESTERN BLOT CONFIRMATORY TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1597951 DIASORIN LIASON XL HSV 1 ENZYME LINKED IMMUNOSORBENT ASSAY, HERPES SIMPLEX VIRUS, HSV-1 MXJ DIASORIN INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Female Other