BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VAXCEL IMPLANTABLE VASCULAR ACCESS PORT

    MDR report key: 2103348 · Received May 22, 2011

    Report

    Report Number
    MW5020697
    Event Type
    Injury
    Date Received
    May 22, 2011
    Date of Event
    March 12, 2009
    Report Date
    May 22, 2011
    Manufacturer
    BOSTON SCIENTIFIC MEDI TECH
    Product Code
    LJT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2009, I HAD A VAXCEL BOSTON SCIENTIFIC IMPLANTABLE PORT PLACED IN MY RIGHT ARM FOR CHEMOTHERAPY. THIS WAS IMPLANTED BY A DR AT (B)(6) HOSP IN (B)(6). ON (B)(6) 2009, I WAS DIAGNOSED WITH SEPTIC BURSITIS AND HAD TO BE PUT IN THE HOSP FOR 12 DAYS. THE PORT WAS REMOVED AND I HAD A VERY SERIOUS INFECTION. I WAS IN A LOT OF PAIN AND HAD TO STOP MY CHEMOTHERAPY UNTIL THE INFECTION COULD BE CONTROLLED. I FEEL THIS PORT CAUSED MY INFECTION AND ALMOST MY DEATH. I ALSO THINK THIS INFECTION FURTHER WEAKENED MY IMMUNE SYSTEM. THIS VAXCEL PORT WAS (B)(4), LOT NUMBER 1166242.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VAXCEL IMPLANTABLE VASCULAR ACCESS PORT NONE LJT BOSTON SCIENTIFIC MEDI TECH 45-315

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| L| O| R| S