BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRACH HEAT & MOISTURE

    MDR report key: 926162 · Received October 4, 2007

    Report

    Report Number
    MW5004024
    Event Type
    Malfunction
    Date Received
    October 4, 2007
    Date of Event
    October 1, 2007
    Report Date
    October 4, 2007
    Manufacturer
    KIMBERLY-CLARK
    Product Code
    BYD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    KIMBERLY-CLARK TRACHEOSTOMY HEAT AND MOISTURE EXCHANGER. LOT NUMBERS 0200942, 360476, 0201076. ALL LOT NUMBERS CONTAINS AN OILY MOISTURE SUBSTANCE IN THE DEVICE. MANUFACTURER REPRESENTATIVE PICKED UP PRODUCT AND VERIFIED DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRACH HEAT & MOISTURE NONE BYD KIMBERLY-CLARK 0200942
    2 TRACH HEAT & MOISTURE EXCHANGER NONE BYD KIMBERLY-CLARK 360476
    3 TRACH HEAT & MOISTURE EXCHANGER NONE BYD KIMBERLY-CLARK 0201076

    Patients

    Seq Age Sex Outcome Treatment
    1 YR