BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOMETER

    MDR report key: 12878255 · Received November 24, 2021

    Report

    Report Number
    MW5105606
    Event Type
    Injury
    Date Received
    November 24, 2021
    Date of Event
    November 24, 2021
    Report Date
    November 24, 2021
    Manufacturer
    UNK
    Product Code
    PZI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT CALLED TO REPORT DEVICE ISSUES WITH 3 DIFFERENT DEVICES USED AT THE FACILITY WHERE HE IS A RESIDENT. PATIENT STATED THAT THE THERMOMETER, GLUCOMETER, AND BLOOD PRESSURE MEASURING DEVICE USED AT THE FACILITY GIVE INACCURATE READINGS, ERROR MESSAGES, AND FEELS THE DEVICES NEED TO BE CHECKED. PATIENT STATED HE DOES NOT FEEL THE DEVICES AT THE FACILITY ARE UP TO CODE AND ARE DEFECTIVE. PATIENT STATED HE'S HAD AN ONGOING GROIN INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1770082 THERMOMETER THERMOMETER, ELECTRONIC, CLINICAL PZI UNK
    1770083 GLUCOMETER PRESCRIPTION USE BLOOD GLUCOSE METER FOR NEAR-PATIENT TESTING PZI UNK
    1770084 ELECTRONIC BLOOD PRESSURE DEVICE ALARM, BLOOD-PRESSURE PZI UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other