BEUDAMED
    FDA Adverse Event Other Summary report: N

    DIATEK THERMOMETER

    MDR report key: 486918 · Received September 23, 2003

    Report

    Report Number
    1316463-2003-00004
    Event Type
    Other
    Date Received
    September 23, 2003
    Date of Event
    July 27, 2003
    Report Date
    September 23, 2003
    Manufacturer
    WELCH ALLYN, INC.
    Product Code
    FLL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A RECTAL TEMPERATURE WAS BEING TAKEN. UPON REMOVING THE PROBE, THE PROBE COVER BROKE. THE BREAK WAS CIRCUMFERENTIAL. THE EDGES WERE SMOOTH WHERE THE PROBE COVER BROKE APART. PART OF THE PROBE COVER REMAINED LODGED IN THE PATIENT. THE PATIENT WAS SENT TO A NEARBY HOSPITAL WHERE AN ENDOSCOPIC PROCEDURE FAILED TO REMOVE THE PROBE COVER. ENEMAS WERE ADMINISTERED TO THE PATIENT, BUT THE PROBE COVER WOULD NOT PASS. FINALLY IN 2003, THE PROBE COVER DID PASS WITH NO INJURY SUFFERED BY THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIATEK THERMOMETER ELECTRONIC CLINICAL THERMOMETER FLL WELCH ALLYN, INC. 600 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization