BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIRST TO KNOW. HOME SYPHILIS TEST

    MDR report key: 21276190 · Received January 30, 2025

    Report

    Report Number
    MW5165445
    Event Type
    Malfunction
    Date Received
    January 30, 2025
    Date of Event
    January 20, 2025
    Report Date
    January 25, 2025
    Manufacturer
    NOWDIAGNOSTICS, INC.
    Product Code
    SBZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    GOT A FALSE POSITIVE ON THE HOME SYPHILIS TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520211 FIRST TO KNOW. HOME SYPHILIS TEST TEST FOR DETECTION OF ANTIBODIES ASSOCIATED WITH SYPHILIS PERFORMED BY LAY USERS SBZ NOWDIAGNOSTICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male DOXYPEP| MEN'S DAILY 50+ MULTIVITAMIN/MINERAL SUPPLEMENT| PREP