BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VDTS-100R

    MDR report key: 22714205 · Received August 5, 2025

    Report

    Report Number
    22714205
    Event Type
    Malfunction
    Date Received
    August 5, 2025
    Date of Event
    June 8, 2025
    Report Date
    July 23, 2025
    Manufacturer
    EKLA CORPORATION
    Product Code
    FLL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    NOVA PLUS STANDARD DIGITAL THERMOMETERS DEFECTIVE. THREE THERMOMETERS GAVE THE WRONG RECTAL TEMPERATURE. MODEL # CAT. NO. VDTS-100R, FROM LOT# (B)(4) 20241113. PRODUCT WAS DISCARDED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2756403 VDTS-100R CONTINUOUS MEASUREMENT THERMOMETER FLL EKLA CORPORATION 20241113

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown