BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITAL TEMP

    MDR report key: 2620593 · Received June 12, 2012

    Report

    Report Number
    1718887-2012-00001
    Event Type
    Injury
    Date Received
    June 12, 2012
    Date of Event
    May 1, 2012
    Report Date
    May 17, 2012
    Manufacturer
    VITAL SIGNS COLORADO, INC.
    Product Code
    FLL
    PMA / PMN Number
    K925791
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DATA NOT CURRENTLY AVAILABLE. THE EVENT WAS KNOWN TO HAVE OCCURRED IN (B)(6) 2012, BUT THE SPECIFIC DATE IS UNKNOWN. AS THE LOT NUMBER OF THE DEVICE IS UNKNOWN, THE MANUFACTURER DATE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A NOSE BLEED AFTER THE TEMPERATURE PROBE WAS INSERTED THROUGH THE NASOPHARYNX. IT WAS REPORTED THAT AND EAR, NOSE, AND THROAT SURGEON HAD TO BE CALLED, "FROM ANOTHER THEATRE AS THEY COULD NOT STOP THE NOSE BLEED ON A PATIENT WHO HAD JUST HAD THE TEMP PROBE INSERTED. THIS ONLY INVOLVED PACKING THE NASAL CAVITY FOR A SHORT TIME TO STOP THE BLEEDING." GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITAL TEMP TEMPERATURE PROBE FLL VITAL SIGNS COLORADO, INC. 1016EU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention