BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE ILS CURVED CIR STAPL

    MDR report key: 2900164 · Received January 7, 2013

    Report

    Report Number
    3005075853-2013-00105
    Event Type
    Injury
    Date Received
    January 7, 2013
    Date of Event
    December 3, 2012
    Report Date
    December 19, 2012
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A RIGHT HEMICOLECTOMY AND ANTERIOR RESECTION PROCEDURES PERFORMED ON (B)(6) 2012 THE PATIENT EXPERIENCED EXCESSIVE POST OPERATIVE BLEEDING WITHIN A 24 HOUR PERIOD. TOTAL AMOUNT BLOOD LOSS NOT REPORTED. THE PATIENT REQUIRED A BLOOD TRANSFUSION. A GIA STAPLER WAS ALSO USED DURING PROCEDURE. DEVICE WAS DISCARDED. THERE WAS NO OTHER REPORTED PATIENT CONSEQUENCE. ADDITIONAL FOLLOW UP IS BEING CONDUCTED. IF ADDITIONAL DETAILS BECOME AVAILABLE A 3500 A SUPPLEMENTAL WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6305 PROXIMATE ILS CURVED CIR STAPL STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention