BEUDAMED
    FDA Adverse Event Death Summary report: N

    BLAKE DRAIN

    MDR report key: 2502196 · Received March 23, 2012

    Report

    Report Number
    2210968-2012-00830
    Event Type
    Death
    Date Received
    March 23, 2012
    Report Date
    February 29, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    KOG
    PMA / PMN Number
    K953655
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE BATCH NUMBERS: BATCH J1111229 MFG DATE: 06/01/2011, EXP DATE: 06/30/2016, BATCH J1111230 MFG DATE: 06/01/2011, EXP DATE: 06/30/2016, BATCH J1114716 MFG DATE: 08/01/2011, EXP DATE: 08/31/2016, BATCH J1116807 MFG DATE: 08/01/2011, EXP DATE: 08/31/2016. 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. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2012-00831. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PANCREATODUODENECTOMY PROCEDURE ON (B)(6) 2011 AND A DRAIN WAS PLACED AT THE FRONT OF THE PANCREAS-JEJUNUM ANASTOMOSIS AREA AND WAS CONNECTED TO A RESERVOIR. THE PATIENT DEVELOPED A PANCREATIC FISTULA. THE SURGEON OPINES THAT THE DRAIN DID NOT CAUSE OR CONTRIBUTE TO THE PANCREATIC FISTULA FORMATION. THE DRAIN SUCTIONED THE PANCREATIC FISTULA FLUID, BUT THERE WAS HIGH FLUID FLOW VOLUME. AS A RESULT, THE PANCREATIC FLUID GATHERED IN AN UNEXPECTED LOCATION AND DAMAGED BLOOD VESSELS IN THE AREA BY MEANS OF ENZYMATIC DIGESTION. THE PATIENT EXPIRED ON AN UNKNOWN DATE. THE PRIMARY CAUSE OF THE PATIENT'S DEATH WAS BLEEDING FROM DAMAGED ORGAN VESSELS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R