BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HSV 2 VAGINAL PCR SWAB

    MDR report key: 18667954 · Received February 7, 2024

    Report

    Report Number
    MW5151179
    Event Type
    Malfunction
    Date Received
    February 7, 2024
    Date of Event
    February 1, 2024
    Report Date
    February 5, 2024
    Manufacturer
    UNK
    Product Code
    OQO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    117
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    VAGINAL PCR RETURNED WITH PATIENT INITIALLY POSITIVE WITH HSV II, REPEAT SWAB SHOWED NO HSV II. PATIENT DID NOT EXPERIENCE VESICLES OR ANY SIGNS OF OUTBREAK WITH POSITIVE DIAGNOSIS. REPEAT SWAB SHOWED NO HSV II, SAME LAB AND SAME SAMPLE COLLECTION TECHNIQUE; VIKOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1366072 HSV 2 VAGINAL PCR SWAB HERPES SIMPLEX VIRUS NUCLEIC ACID AMPLIFICATION ASSAY OQO UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Other