BEUDAMED
    FDA Adverse Event Injury Summary report: N

    75MM SELECTABLE NEW TLC

    MDR report key: 2823192 · Received November 7, 2012

    Report

    Report Number
    3005075853-2012-05061
    Event Type
    Injury
    Date Received
    November 7, 2012
    Date of Event
    September 1, 2012
    Report Date
    October 17, 2012
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K092577
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST OP A LAPAROSCOPIC COLECTOMY PROCEDURE, 7-10 DAYS POST OP THE PATIENT HAD A LEAK. A PERCUTANEOUS DRAIN WAS PLACED. THERE WAS NO OTHER PATIENT CONSEQUENCES REPORTED. THE SURGEON DOES NOT WISH TO DISCUSS FURTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 75MM SELECTABLE NEW TLC STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention