BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTACK 5MM INSTRUMENT

    MDR report key: 1900226 · Received November 10, 2010

    Report

    Report Number
    2647580-2010-00890
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    October 14, 2010
    Report Date
    October 19, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    KOG
    PMA / PMN Number
    K963999
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: HERNIA. ACCORDING TO THE REPORTER: WHEN FIXING THE MESH, THE TACKS WERE NOT APPLIED PROPERLY; THEY HAD TO CUT THE MESH AS SOME STAPLES WERE TWINED INSIDE THE MESH. THEY SUTURED THE DAMAGED TISSUE AND RE-STAPLED WITH ANOTHER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTACK 5MM INSTRUMENT DISPOSABLE STAPLING DEVICE KOG USSC PUERTO RICO P0D0465

    Patients

    Seq Age Sex Outcome Treatment
    1 Other