BEUDAMED
    FDA Adverse Event Injury Summary report: N

    75MM SELECTABLE NEW TLC

    MDR report key: 2072093 · Received April 28, 2011

    Report

    Report Number
    3005075853-2011-01773
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    March 30, 2011
    Report Date
    April 14, 2011
    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
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST OP OF A GYN PROCEDURE, THE PATIENT HAD AN ANASTOMOSIS LEAK; UNKNOWN HOW MANY DAYS POST OP. THE PATIENT PRESENTED WITH INDICATIONS OF A POST OP LEAK AND AN UNKNOWN SCAN WAS PERFORMED TO CONFIRM. MEDICATIONS WERE GIVEN TO THE PATIENT FOR THE LEAK. THE DEVICE FUNCTIONED NORMALLY DURING THE ORIGINAL CASE. THE PATIENT IS DOING WELL. THE DEVICE WAS DISCARDED. ADDITIONAL INFORMATION BEING REQUESTED.

    Description of Event or Problem · 1

    NO ADDITIONAL INFORMATION AVAILABLE ABOUT EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R CARTRIDGE