BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORA-KLEX CHEST DRAIN SYSTEM

    MDR report key: 261951 · Received February 11, 2000

    Report

    Report Number
    1221601-2000-00001
    Event Type
    Death
    Date Received
    February 11, 2000
    Date of Event
    January 17, 2000
    Report Date
    January 27, 2000
    Manufacturer
    GENZYME SURGICAL PRODUCTS CORP.
    Product Code
    KDQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PT DEATH WAS REPORTED. DURING THE PT STAY IN POST-OP, A THORA-KLEX UNIT WAS CONNECTED UP TO SUCTION AND REPORTED TO NOT FUNCTION. A SECOND UNIT WAS PUT IN PLACE AND FUNCTIONED PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THORA-KLEX CHEST DRAIN SYSTEM CHE DRAINAGE DEVICE KDQ GENZYME SURGICAL PRODUCTS CORP. 0077000 369333

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death