BEUDAMED
    FDA Adverse Event Summary report: N

    ATRIUM MEDICAL CORPORATION

    MDR report key: 348845 · Received August 20, 2001

    Report

    Report Number
    1219977-2001-00001
    Date Received
    August 20, 2001
    Date of Event
    August 6, 2001
    Report Date
    August 16, 2001
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    DSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2001, IMPLANTED AN ATRIUM GRAFT, LOT NUMBER A90700503, INTO A RENAL PT IN THE FEMORAL POSITION FOR DIALYSIS. A MEDINORN 1/8" DRAINAGE SYSTEM WAS PLACED. DURING THE PT'S TIME IN RECOVERY, IT WAS NOTED THAT THE PT HAD LOST APPROX 1.5 LTR OF LIGHT RED FLUID FROM PT'S WOUND SITE INTO THE DRAINAGE SYSTEM. THIS FLUID WAS ALSO REPORTED BY THE RECOVERY STAFF TO BE OOZING FROM ONE OF THE LOWER INCISION SITES. THE PT WAS TAKEN BACK TO THEATRE. WHEN RE-OPENED REPORTER STATED, "FLUID APPEARED TO BE OOZING FROM THE CENTRAL SECTION OF THE GRAFT. THE GRAFT WAS REMOVED AND REPLACED WITH ATRIUM GRAFT, LOT NUMBER A90750410. UNFORTUNATELY, THE PT HAS DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37890 ATRIUM MEDICAL CORPORATION SYNTHETIC GRAFT DSY ATRIUM MEDICAL CORP. * A90700503

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death