BEUDAMED
    FDA Adverse Event Death Summary report: N

    SM ATT PLAS+8FR GROSH+KI

    MDR report key: 377412 · Received February 18, 2002

    Report

    Report Number
    1720496-2002-00021
    Event Type
    Death
    Date Received
    February 18, 2002
    Date of Event
    January 11, 2002
    Report Date
    January 22, 2002
    Manufacturer
    BARD REYNOSA S.A. DE C.V.
    Product Code
    LJT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SINCE DOCTOR PENETRATED THE "SHEATH" WITH THE DILATOR DURING DILATION, BLOOD VESSEL OF THE PT WAS DAMAGED AND THE PT DIED OF HEMORRHAGIC SHOCK. EVENTUALLY PLACEMENT OF THE PORT WAS NOT PERFORMED. THE PT WAS AT THE END STAGE OF ESOPHAGEAL CANCER. THE DOCTOR ADMITS HIS USE THAT IGNORED CONTRAINDICATION OF "PAST IRRADIATION OF PROSPECTIVE INSERTION SITE" AND HIS MISTAKE DURING THE PROCEDURE. NO OTHER INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SM ATT PLAS+8FR GROSH+KI INTRAVASCULAR IMPLANTED ACCESS DEVICE LJT BARD REYNOSA S.A. DE C.V. 0602830 22CL5582

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death