BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TA 90 - 3.5 SINGLE USE RELOADABLE

    MDR report key: 1944479 · Received December 28, 2010

    Report

    Report Number
    2647580-2010-01009
    Event Type
    Injury
    Date Received
    December 28, 2010
    Report Date
    December 3, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GDW
    PMA / PMN Number
    K013860
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: COLON RESECTION. ACCORDING TO THE REPORTER: THIS INCIDENT WAS A POST-OP LEAK. THE DOCTOR SCHEDULED THE PT FOR A RE-OP. ADDITIONAL INFO WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TA 90 - 3.5 SINGLE USE RELOADABLE DISPOSABLE SURGICAL STAPLER GDW USSC PUERTO RICO P0J0521

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R