BEUDAMED
    FDA Adverse Event Death Summary report: N

    HUDSON DUAL LIMB HEATED CIRCUIT

    MDR report key: 1616430 · Received February 23, 2010

    Report

    Report Number
    3003898360-2010-00087
    Event Type
    Death
    Date Received
    February 23, 2010
    Report Date
    February 9, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BZE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO SAMPLE OR LOT# BEING RETURNED FOR INVESTIGATION. A FOLLOW-UP INVESTIGATION REPORT WILL BE SENT WHEN COMPLETED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: COMPLAINT INDICATES THAT AN ALLEGED DEATH OCCURRED DUE TO A MUCUS PLUG. COMPLAINT ALSO STATES THAT ALTHOUGH TELEFLEX PRODUCTS WERE USED, NONE OF THE EQUIPMENT FAILED. THE PRODUCT WORKED AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON DUAL LIMB HEATED CIRCUIT HEATED CIRCUIT BZE TELEFLEX MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death