BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVAPLUS DIGITAL THERMOMETER, PEDIATRIC, DUCK CAP

    MDR report key: 15293465 · Received August 25, 2022

    Report

    Report Number
    15293465
    Event Type
    Malfunction
    Date Received
    August 25, 2022
    Date of Event
    August 3, 2022
    Report Date
    August 23, 2022
    Manufacturer
    ELKA CORPORATION
    Product Code
    FLL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHEN RN REMOVED THERMOMETER FROM PACKAGE, DUCK HEAD CAME OFF. THIS IS A SAFETY ISSUE AS A CHILD COULD CHOKE ON THE HEAD. IN ADDITION, THERE IS A BUTTON BATTERY RIGHT UNDER THE DUCK HEAD. BUTTON BATTERIES CAN CAUSE SERIOUS INJURY OR DEATH IF SWALLOWED. NURSING STAFF SUGGEST MANUFACTURER MAKE THE DEVICE WITH A SINGLE BATTERY WITHOUT POP OFF TOP. MANUFACTURER RESPONSE FOR PEDIATRIC FLEXIBLE TIP DIGITAL THERMOMETER, NOVAPLUS DIGITAL STICK THERMOMETER PER SITE REPORTER. I RECEIVED AN EMAIL FROM MANUFACTURER'S OFFICIAL PERSON IN ADDITION TO A PHONE CALL FROM A ELKA REPRESENTATIVE QUALITY TEAM. DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR INVESTIGATION. AWAITING RESPONSE AND MAILING LABELS TO PROCESS RETURN OF PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2393269 NOVAPLUS DIGITAL THERMOMETER, PEDIATRIC, DUCK CAP THERMOMETER, ELECTRONIC, CLINICAL FLL ELKA CORPORATION 20210108

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown