BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE FEVER READER

    MDR report key: 20174 · Received March 8, 1995

    Report

    Report Number
    MW1005363
    Event Type
    Malfunction
    Date Received
    March 8, 1995
    Report Date
    March 7, 1995
    Manufacturer
    APOTHECARY PRODUCTS, INC.
    Product Code
    KPD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AS YOU CAN SEE, THE REPORT CONTAINS NO REAL DATA SO WE ARE UNABLE TO OFFER ANY REAL DIRECTION. THERE IS NO INDICATION ON HOW LONG THE FEVER READER WAS LEFT IN POSITION ON THE INFANT'S FOREHEAD NOR DOES IT EVEN TELL US WHETHER IT WAS PLACED RIGHT SIDE UP. IN ADDITION, IT DOES NOT TELL US WHETHER THE FEVER READER WAS CLEAN FROM PREVIOUS USAGE.

    Description of Event or Problem · 1

    CO HAS SET UP AN FDA FILE ON THIS MATTER BUT WITHOUT SUFFICIENT INFO CO IS UNABLE TO EVALUATE WHETHER CO NEEDS TO REPORT THIS COMPLAINT OR NOT. CO HAS HAD NO OTHER COMPLAINTS AND ALL INVENTORY CHECKED WAS CORRECT AND IN GOOD WORKING ORDER. DATA MISSING IS: 1. THE LOT NUMBER ON THE BACK OF THE STRIP WHICH ALOOWS CO TO MATCH AGAINST THE RETAINED SAMPLE. 2. HOW THE OPERATOR USED THE STRIP AND IF INSTRUCTIONS ON PROPER USAGE FOLLOWED. WITH THE ABOVE INFO, CO CAN CERTAINLY BE MORE RESPONSIVE TO THE REPORTER'S NEEDS AND CONCERNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THE FEVER READER STRIP FOR TAKING TEMPERATURE KPD APOTHECARY PRODUCTS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 *