BEUDAMED
    FDA Adverse Event Other Summary report: N

    CARDINAL HEALTH-JACKSON PRATT DRAIN

    MDR report key: 1084403 · Received April 30, 2008

    Report

    Report Number
    1084403
    Event Type
    Other
    Date Received
    April 30, 2008
    Date of Event
    January 3, 2008
    Report Date
    January 30, 2008
    Manufacturer
    CARDINAL HEALTH
    Product Code
    GCY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2007, PT HAD EMERGENT LAPAROSCOPIC GRAHAM PATCH REPAIR FOR A PERFORATED ULCER. PRIOR TO PROCEDURE COMPLETION, 15-F ROUND JACKSON-PRATT DRAIN WAS PLACED BY SURGEON THROUGH RIGHT MID ABDOMINAL TROCAR SITE AROUND THE GRAHAM PATCH REPAIR AND UNDERNEATH THE LATERAL SEGMENT OF THE LEFT LOBE OF THE LIVER. THE DRAIN WAS SUTURED IN PLACE WITH A 2-0 SILK SUTURE. AT APPROX 11 DAYS LATER, JACKSON-PRATT DRAIN WAS REMOVED AT BEDSIDE AND PT DISCHARGED FROM HOSPITAL. PT RETURNED BACK TO HOSPITAL ABOUT 5 WEEKS LATER WITH COMPLAINT OF NAUSEA AND VOMITING. CAT SCAN OF ABDOMEN NOTED 4.5CM CATH FRAGMENT IN 2008. PT HAD A LAPAROSCOPIC REMOVAL OF INTRAPERITONEAL FOREIGN BODY (JACKSON-PRATT DRAIN)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDINAL HEALTH-JACKSON PRATT DRAIN JACKSON-PRATT 15 F ROUND DRAIN GCY CARDINAL HEALTH UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other