BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-CATH ESOPHAGEAL TEMPERATURE PROBE

    MDR report key: 17627653 · Received August 25, 2023

    Report

    Report Number
    3009437315-2023-00003
    Event Type
    Injury
    Date Received
    August 25, 2023
    Report Date
    August 25, 2023
    Manufacturer
    CIRCA SCIENTIFIC, INC.
    Product Code
    FLL
    UDI-DI
    10860237000214
    PMA / PMN Number
    K112376
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO ALLEGED DEFECT WITH PROBE OR INSTRUCTIONS. PROBE WAS DISCARDED BY THE HOSPITAL AFTER USE, AND THEREFORE NO VISUAL INSPECTION OF THE COMPLAINT PROBE COULD BE PERFORMED. EVENT MAY HAVE OCCURRED DUE TO USER NOT FOLLOWING INSTRUCTIONS AND PLACING PROBE DESPITE RESISTANCE BEING FELT DURING DEVICE INTRODUCTION.

    Description of Event or Problem · 0

    A PATIENT HAD A PERFORATION IN THEIR THROAT AND THEY THINK IT MAY BE FROM WHEN THE CRNA INTRODUCED THE PROBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1386386 S-CATH ESOPHAGEAL TEMPERATURE PROBE ESOPHAGEAL TEMPERATURE PROBE FLL CIRCA SCIENTIFIC, INC. CS-2001 UNKNOWN 10860237000214

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization