BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD 14.3 FRENCH

    MDR report key: 1781546 · Received July 22, 2010

    Report

    Report Number
    MW5016851
    Event Type
    Injury
    Date Received
    July 22, 2010
    Date of Event
    July 9, 2010
    Report Date
    July 22, 2010
    Manufacturer
    BARD
    Product Code
    LJT
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WITH OVARIAN CANCER WHO RECEIVED INTRAPERITONEAL CHEMOTHERAPY HAD INTRAPERITONEAL PORT PLACEMENT (B)(6) 2009. UPON COMPLETION OF CHEMOTHERAPY TREATMENTS, INTRAPERITONEAL PORT WAS REMOVED (B)(6) 2010. A CT SCAN OF ABDOMEN AND PELVIS DONE (B)(6) 2010 REVEALED AN ENHANCING FOCUS ALONG THE PRIOR PORT TRACT IN THE ANTERIOR ABDOMINAL WALL. AN ABDOMINAL SURGICAL PROCEDURE DONE (B)(6) 2010 TO REMOVE SUBCUTANEOUS FOREIGN BODY REVEALED A RETAINED DACRON CUFF FROM PRIOR INTRAPERITONEAL PORT. DATES OF USE: (B)(6) 2009 -(B)(6) 2010. DIAGNOSIS OR REASON FOR USE: ADMINISTRATION OF INTRAPERITONEAL CHEMOTHERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD 14.3 FRENCH PERITONEAL TITANIUM PORT WITH ATTACHED 14.3 PERITONEAL CATHETER LJT BARD 0603000

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention