BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NSEAL

    MDR report key: 2052480 · Received April 13, 2011

    Report

    Report Number
    3005075853-2011-01474
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    March 29, 2011
    Report Date
    March 30, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    K072177
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE DAY POST-OP TO A J-POUCH PROCEDURE, THE PATIENT WAS BROUGHT BACK TO SURGERY DUE TO THE BLEEDING OF A MIDDLE COLIC VESSEL. THE PATIENT REQUIRED A BLOOD TRANSFUSION BUT ADDITIONAL DETAILS ARE NOT AVAILABLE AT THIS TIME. THE PATIENT WAS REPORTED IN STABLE CONDITION. THE DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NSEAL ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GENERATOR