BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLAKE DRAIN

    MDR report key: 1809684 · Received August 13, 2010

    Report

    Report Number
    2210968-2010-00930
    Event Type
    Injury
    Date Received
    August 13, 2010
    Date of Event
    April 22, 2006
    Report Date
    July 15, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    KOG
    PMA / PMN Number
    P953655
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. ADDITIONAL INFORMATION: THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE BATCH NUMBERS: BATCH 43979ISP: MFG DATE: 01/26/2006, EXP DATE: 03/31/2011. BATCH 43906ISP: MFG DATE: 01/24/2006, EXP DATE: 03/31/2011. BATCH 43775ISP: MFG DATE: 12/21/2005, EXP DATE: 02/28/2011. BATCH 43827ISP: MFG DATE: 01/13/2006, EXP DATE: 02/28/2011. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS FOR THE POSSIBLE BATCH NUMBERS WAS CONDUCTED AND THE BATCHES MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WITH BILE DUCT CANCER UNDERWENT A PANCREATODUODENECTOMY ON (B)(6) 2006 AND A DRAIN WAS PLACED IN THE ABDOMEN. ON (B)(6) 2006, THERE WAS A SWELLING NOTED AROUND THE INSERTION SITE OF THE DRAIN. ON (B)(6) 2006, THERE WAS AN ACCUMULATION OF BLOOD AROUND THE INSERTION SITE OF THE DRAIN DETERMINED BY CT SCAN. THE SURGEON OPINES THE BLEEDING WAS CAUSED BY THE TROCAR INJURING THE ARTERY OF THE MUSCULUS OBLIQUUS EXTERNUS ABDOMINIS DURIN INSERTION. THERE WAS NO INTERVENTION FOR THE ACCUMULATION OF BLOOD AND NO BLOOD TRANSFUSIONS WERE GIVEN TO THE PATIENT. ON (B)(6) 2006, THE PATIENT DIED OF PRIMARY DISEASE OF THE HEPATIC ARTERY AND A FALSE ANEURYSM RUPTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLAKE DRAIN WOUND DRAINAGE SYSTEM KOG ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention