BEUDAMED
    FDA Adverse Event Death Summary report: N

    PTFE FELT

    MDR report key: 4216884 · Received October 22, 2014

    Report

    Report Number
    2020394-2014-00467
    Event Type
    Death
    Date Received
    October 22, 2014
    Date of Event
    August 17, 2014
    Report Date
    October 3, 2014
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DXZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER FOR THE DEVICE HAS BEEN PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED ONE MONTH POST SURGICAL PROCEDURE, EVIDENCE OF VEGETATIVE GROWTH WAS IDENTIFIED. THE PATIENT EXPIRED TWO MONTHS POST SURGERY. THE CAUSE OF DEATH AND RELATIONSHIP TO THE DEVICE IS UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674227 PTFE FELT PTFE FELT DXZ BARD PERIPHERAL VASCULAR, INC. HUYA0437

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Female Death