BEUDAMED
    FDA Adverse Event Injury Summary report: N

    Medline

    MDR report key: 12819945 · Received November 16, 2021

    Report

    Report Number
    1417592-2021-00202
    Event Type
    Injury
    Date Received
    November 16, 2021
    Date of Event
    October 1, 2021
    Report Date
    November 16, 2021
    Manufacturer
    MEDLINE INDUSTRUIES LP
    Product Code
    BZT
    UDI-DI
    10080196551705
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED BY THE FACILITY THAT THE TEMPERATURE PROBE WAS INSERTED INTO THE PATIENT AND ENDED UP IN THE PATIENT'S RIGHT MAIN STEM. NO ADDITIONAL DETAILS ARE AVAILABLE RELATED TO THE CUSTOMER REPORTED ISSUE. DESPITE MULTIPLE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE CUSTOMER CONTACT WAS UNABLE OR UNWILLING TO PROVIDE FURTHER INCIDENT DETAILS TO THE MANUFACTURER. THE SAMPLE HAS NOT BEEN RETURNED FOR EVALUATION. DUE TO THE REPORTED INCIDENT AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE FACILITY THAT THE TEMPERATURE PROBE WAS INSERTED INTO THE PATIENT AND ENDED UP IN THE RIGHT MAIN STEM. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1721626 Medline TEMPERATURE PROBE 9FR W/400 SERIES TEMP BZT MEDLINE INDUSTRUIES LP DYNJAER4009 10080196551705

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other