BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTL POWERPORT TI, 8FR, CHRONOFLEX INT WSP, ATT, S

    MDR report key: 2594001 · Received May 25, 2012

    Report

    Report Number
    3006260740-2012-00165
    Event Type
    Death
    Date Received
    May 25, 2012
    Date of Event
    May 18, 2011
    Report Date
    May 11, 2012
    Manufacturer
    BARD REYNOSA S.A. DE C.V.
    Product Code
    LJT
    PMA / PMN Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION, AS THE DEVICE IS NO LONGER AVAILABLE. A LOT HISTORY REVIEW (LHR) OF REUG1135 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    SURGEON IS CONFIDENT THAT THE PATIENT'S DEATH HAD NOTHING TO DO WITH THE PORT ITSELF BUT RATHER A CASE OF VERY SICK PATIENT WHOSE UNDERLYING MEDICAL CONDITIONS WERE TO BLAME. SURGEON MENTIONED 'THAT THE PATIENT DIED EITHER HAVING THE PORT INSERTED OR SOON THEREAFTER...'

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTL POWERPORT TI, 8FR, CHRONOFLEX INT WSP, ATT, S SUBCUTANEOUS, INTRAVASCULAR IMPLANTED PORT & CATHETER LJT BARD REYNOSA S.A. DE C.V. REUG1135

    Patients

    Seq Age Sex Outcome Treatment
    1 Death