BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS FLEX ARTICNG

    MDR report key: 2102791 · Received May 25, 2011

    Report

    Report Number
    3005075853-2011-02126
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Report Date
    May 4, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. ONLY THE DEVICE WAS RETURNED FOR EVALUATION. NO PACKAGING MATERIALS WERE RETURNED SO COMPLAINT EVENT CANNOT BE VERIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A HOLE IN THE STERILE PACKAGE. THE DEVICE WAS NOT USED AND WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETS FLEX ARTICNG STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK G4TL0K

    Patients

    Seq Age Sex Outcome Treatment
    1