BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIASORIN LIASON XL HSV 1

    MDR report key: 17225997 · Received June 28, 2023

    Report

    Report Number
    MW5118937
    Event Type
    Injury
    Date Received
    June 28, 2023
    Date of Event
    May 1, 2023
    Report Date
    June 26, 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 = 1.22), FOLLOWED UP WITH A WESTERN BLOT WHICH WAS NEGATIVE FOR HSV 1 AND 2. DATE GIVEN IS THE WESTERN BLOT CONFIRMATORY TEST. REFERENCE REPORT: MW5118938.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460945 DIASORIN LIASON XL HSV 1 ENZYME LINKED IMMUNOSORBENT ASSAY, HERPES SIMPLEX VIRUS, HSV-1 MXJ DIASORIN INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Male Other