BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COR TEMP BODY CORE TEMPERATURE SENSOR

    MDR report key: 345599 · Received August 3, 2001

    Report

    Report Number
    MW1022549
    Event Type
    Injury
    Date Received
    August 3, 2001
    Date of Event
    July 1, 2001
    Report Date
    July 27, 2001
    Manufacturer
    HTI TECHNOLOGIES INC
    Product Code
    FLL
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A TEST VOLUNTEER, PARTICIPATING IN AN INSTITUTIONAL REVIEW BOARD-APPROVED FIELD STUDY HAD DIFFICULTY SWALLOWING ANY FLUIDS AFTER TAKING A THERMOMETER PILL. DIFFICULTY SWALLOWING WATER AFTER INGESTION OF THE THERMOMETER PILL WAS IMMEDIATELY REPORTED BY THE TEST VOLUNTEER, WITH DISCOMFORT AT THE MID-CHEST LEVEL NOTED WHEN WATER WAS CONSUMED. THE TEST VOLUNTEER WAS NOT IN ANY OTHER APPARENT DISTRESS. CHEST X-RAY EXAMINATION AT HOSP ER SHOWED THE THERMOMETER PILL AT THE MID-ESOPHAGEAL LEVEL. THE THERMOMETER PILL (10MM X 22MM) WAS REMOVED ENDOSCOPICALLY WITHOUT COMPLICATIONS AT THE ER OF THE MED CTR USING A 13 MM SNARE. THE THERMOMETER PILL, NOTED AT 33 CM FROM THE GUMS, APPEARED INTACT AND UNREMARKABLE, WITH OBSTRUCTION APPARENTLY DUE TO MODERATE PREEXISTING FELINIZATION OF THE ESOPHAGUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35304 COR TEMP BODY CORE TEMPERATURE SENSOR THERMOMETER PICC FLL HTI TECHNOLOGIES INC COR-100 171068

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention