BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETS FLEX ARTICNG

    MDR report key: 2181746 · Received July 27, 2011

    Report

    Report Number
    3005075853-2011-03039
    Event Type
    Injury
    Date Received
    July 27, 2011
    Date of Event
    May 25, 2011
    Report Date
    June 30, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): AFTER MULTIPLE ATTEMPTS TO RETRIEVE THE DEVICE NO RESPONSE HAS BEEN RECEIVED.

    Additional Manufacturer Narrative · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETS FLEX ARTICNG STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK H43K6P

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention