BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE** RELOADABLE LINEAR STAPLER

    MDR report key: 3010718 · Received March 19, 2013

    Report

    Report Number
    3005075853-2013-01281
    Event Type
    Injury
    Date Received
    March 19, 2013
    Report Date
    February 26, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION UNAVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A LAPAROSCOPIC BOWEL RESECTION PROCEDURE, PATIENT DEVELOPED AN INFECTION IN THE LAST TWO WEEKS IN THIS CASE. PHLEGMON OCCURRED ALONG THE BOWEL ANASTOMOSIS. THERE WAS NO RE-OPERATION SO CULTURES WERE UNOBTAINABLE. THE PATIENT WAS ADMITTED AND TREATED WITH IV ANTIBIOTICS AND DISCHARGED IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114439 PROXIMATE** RELOADABLE LINEAR STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention