BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPRA CARBOFLO

    MDR report key: 958525 · Received November 30, 2007

    Report

    Report Number
    MW5004578
    Event Type
    Injury
    Date Received
    November 30, 2007
    Date of Event
    November 28, 2007
    Report Date
    November 30, 2007
    Manufacturer
    BARD
    Product Code
    FIQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PRODUCT WAS BARD IMPRA CARBOFLO POLYTETRAFLUOROETHYLENE PROSTHETIC GRAFT PLACED IN THE LEFT UPPER ARM POSITION. PATIENT DEVELOPED A LARGE SEROMA OF THE AXILLA. ON EXPLORATION OF THE LEFT UPPER ARM, THE GRAFT WAS SEEN TO HAVE EXCESSIVELY LARGE AMOUNT SERUM "WEEPING" -ULTRAFILTRATING- THROUGH THE WALL ADJACENT TO THE ARTERIAL ANASTAMOSIS. DATES OF USE: 2007. DIAGNOSIS OR REASON FOR USE: DIALYSIS ACCESS. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED? YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPRA CARBOFLO DIALYSIS GRAFT FIQ BARD

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Life Threatening| S