BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-CATH M ESOPHAGEAL TEMPERATURE PROBE

    MDR report key: 20869451 · Received December 6, 2024

    Report

    Report Number
    3009437315-2024-00001
    Event Type
    Injury
    Date Received
    December 6, 2024
    Date of Event
    November 6, 2024
    Report Date
    December 6, 2024
    Manufacturer
    CIRCA SCIENTIFIC, INC.
    Product Code
    FLL
    UDI-DI
    01086023700276
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    EXAMINATION SHOWS THE PEBAX LAYER WAS THIN AT THE ELECTRODE BAND EDGES. DURING PROBE INSERTION AND REMOVAL, THE FRICTION CAUSED THE PEBAX TO PEEL AWAY, THEREBY EXPOSING THE ELECTRODE BAND EDGE.

    Description of Event or Problem · 0

    THE CUSTOMER USED A NEW CS-46EP AND REPORTS THAT WHEN THE PROBE WAS REMOVED, THERE WAS RESISTANCE IN THE NOSE, AND IT STARTED TO BLEED HEAVILY; THE BLEEDING COULD ONLY BE STOPPED THE NEXT DAY. HE ALSO REPORTED THAT THE SURFACE OF THE PROBE IN THE AREA OF THE ELECTRODES WAS BADLY DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97351 S-CATH M ESOPHAGEAL TEMPERATURE PROBE ESOPHAGEAL TEMPERATURE PROBE FLL CIRCA SCIENTIFIC, INC. CS-46EP 004814 01086023700276

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization