BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EEA

    MDR report key: 2202448 · Received August 5, 2011

    Report

    Report Number
    2647580-2011-00517
    Event Type
    Injury
    Date Received
    August 5, 2011
    Report Date
    July 25, 2011
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LOW ANTERIOR RESECTION. ACCORDING TO THE REPORTER: THE CUSTOMER REPORTS THAT THE SURGERY WAS COMPLETED WITHOUT PROBLEMS. THE PT WAS RETURNED TO SURGERY 4 DAYS LATER BECAUSE OF A BOWEL CONTENT LEAK. THE BOWEL HAD TO BE DE-FUNCTIONED AND THE PT IS TO RETURN TO SURGERY IN 3 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN EEA DISPOSABLE SURGICAL STAPLING DEVICE GDW USSC PUERTO RICO UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R