BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TCM

    MDR report key: 1621607 · Received February 26, 2010

    Report

    Report Number
    1523456-2010-00002
    Event Type
    Injury
    Date Received
    February 26, 2010
    Date of Event
    August 24, 2009
    Report Date
    February 3, 2010
    Manufacturer
    RADIOMETER MEDICAL APS
    Product Code
    KLK
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, AN E-MAIL WAS SENT TO A LOCAL SALES REPRESENTATIVE REPORTING THE FOLLOWING: DURING A SLEEP STUDY, THE PATIENT WAS MONITORED USING A TRANSCUTANEOUS MONITORING DEVICE AND SUFFERED A BURN TO THE UPPER CHEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TCM TCM4 KLK RADIOMETER MEDICAL APS TCM4 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention