BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON 60

    MDR report key: 2964078 · Received February 15, 2013

    Report

    Report Number
    3005075853-2013-00666
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    December 5, 2012
    Report Date
    January 21, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE HOSPITAL CONTACT REVIEWED THE PAPERWORK AND INDICATED THAT SHE BELIEVES THE PLASTIC FRAGMENT WAS RETRIEVED AND DOESN¿T REMAIN IN THE PATIENT. SHE AGREED TO CONFIRM THIS INFORMATION. SHE WAS OPEN TO GETTING PHOTOGRAPHS OF THE PIECE FOR ETHICON'S REVIEW, BUT FIRST NEEDED TO DETERMINE IF IT OR THE DEVICE WAS SAVED. SHE AGREED TO CONTACT US ONCE SHE CONFIRMED THIS INFORMATION. THE CONTACT NEVER RESPONDED TO ETHICON'S MULTIPLE ATTEMPTS TO CONFIRM THIS INFORMATION NOR DID THE HOSPITAL RETURN THE PRODUCT.

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION IS UNAVAILABLE; DEVICE HAS NOT BEEN RETURNED FOR EVALUATION.(B)(4).

    Description of Event or Problem · 1

    SEE ATTACHED USER FACILITY MEDWATCH REF # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66330 ECHELON 60 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention