BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PWRD ECH FLEX 45MM 34CM SHAFT

    MDR report key: 3241288 · Received July 22, 2013

    Report

    Report Number
    3005075853-2013-03674
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 28, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION UNAVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340397 PWRD ECH FLEX 45MM 34CM SHAFT STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1