BEUDAMED
    FDA Adverse Event Death Summary report: N

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

    MDR report key: 2579898 · Received May 15, 2012

    Report

    Report Number
    3006260740-2012-00159
    Event Type
    Death
    Date Received
    May 15, 2012
    Date of Event
    October 4, 2011
    Report Date
    April 23, 2012
    Manufacturer
    BARD REYNOSA, S.A. DE C.V.
    Product Code
    LJT
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MFR FOR EVAL, AS THE PT IS DECEASED AND THE PORT IS NO LONGER AVAILABLE. A LOT HISTORY REVIEW (LHR) OF REVD1018 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    NO DETAILS OF EVENT. SURGEON IS CONFIDENT THAT THE PT'S DEATH HAD NOTHING TO DO WITH THE PORT ITSELF BUT RATHER A CASE OF VERY SICK PT WHOSE UNDERLYING MEDICAL CONDITIONS WERE TO BLAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTL POWERPORT TI, 8FR, CHRONOFLEX INT WSP, ATT, SI SUBCUTANEOUS, INTRAVASCULAR IMPLANTED PORT & CATHETER LJT BARD REYNOSA, S.A. DE C.V. REVD1018

    Patients

    Seq Age Sex Outcome Treatment
    1 Death