BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE PPH PROCEDURE SET

    MDR report key: 1053128 · Received May 13, 2008

    Report

    Report Number
    1527736-2008-03014
    Event Type
    Injury
    Date Received
    May 13, 2008
    Date of Event
    April 23, 2008
    Report Date
    April 25, 2008
    Manufacturer
    ETHICON ENDO SURGERY, INC. (CINCINNATI)
    Product Code
    GDW
    PMA / PMN Number
    K051301
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE DEVICE CUT, BUT DID NOT STAPLE. THIS RESULTED IN BLEEDING. THE PT HAD TO HAVE A BLOOD TRANSFUSION. THE SURGEON HAND SUTURED TO COMPLETE THE PROCEDURE AND IT WAS EXTENDED 60 MINUTES. THE PT WAS IN THE ICU FOR 3 DAYS BEFORE HE WAS RELEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE PPH PROCEDURE SET GDW ETHICON ENDO SURGERY, INC. (CINCINNATI) NA E4KN7C

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention