BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABSORBATACK 5MM SINGLE USE ABSORBABLE

    MDR report key: 2171111 · Received July 11, 2011

    Report

    Report Number
    1219930-2011-00572
    Event Type
    Injury
    Date Received
    July 11, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 9, 2011
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE DEVICE DID NOT WORK, IT WAS BITING INTO TISSUE. IT WAS REPORTED, TISSUE DAMAGE OCCURRED. IT COULD NOT BE REPORTED HOW THE CASE WAS COMPLETED, IF BLEEDING OCCURRED OR IF THERE WAS A DELAY IN OPERATING ROOM TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABSORBATACK 5MM SINGLE USE ABSORBABLE DISPOSABLE STAPLER PRODUCT GDW UNITED STATES SURGICAL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other