BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TCM3 TINA MONITOR

    MDR report key: 148207 · Received January 9, 1998

    Report

    Report Number
    148207
    Event Type
    Injury
    Date Received
    January 9, 1998
    Date of Event
    June 13, 1997
    Report Date
    July 3, 1997
    Manufacturer
    RADIOMETER AMERICA INC.
    Product Code
    KLK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PROBE FROM TRANSCUTANEOUS OXYGEN MONITOR BURNED CHEST RESULTING IN BLISTER. SETTING AT 43.5 DEGREES C.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TCM3 TINA MONITOR TRANCUTANEOUS OXYGEN MONITOR KLK RADIOMETER AMERICA INC. TCM3-2 *

    Patients

    Seq Age Sex Outcome Treatment
    1 2 DAY Required Intervention