BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECTAL THERMOMETER

    MDR report key: 4407 · Received June 30, 1992

    Report

    Report Number
    4407
    Event Type
    Injury
    Date Received
    June 30, 1992
    Date of Event
    May 15, 1992
    Report Date
    May 22, 1992
    Manufacturer
    IVAC
    Product Code
    EXX
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    ON MAY 15, 1992, WE WE CARING FOR AN EIGHTH (8) MONTH OLD INFANT IN THE EMERGENCY DEPARTMENT. THE NURSE TOOK A RECTAL TEMPERATURE WITH AN IVAC THERMOMETER. THE PROBE COVER BECAME DETACHEFD FROM THE ELECTRONIC STYLET AND WAS SUBSEQUENTLY RETRACTED INTO THE INFANT'S RECTUM. THE PROBE WAS EVENTUALLY RECOVERED WITH THE PATIENT UNDER GENERAL ANESTHESIA ANOTHER FACILITYINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED. INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RECTAL THERMOMETER PROBE EXX IVAC 2000

    Patients

    Seq Age Sex Outcome Treatment
    1 8 MO Required Intervention