BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SALUTE FIXATION DEVICE

    MDR report key: 724860 · Received June 7, 2006

    Report

    Report Number
    1213643-2006-00153
    Event Type
    Injury
    Date Received
    June 7, 2006
    Date of Event
    May 5, 2006
    Report Date
    May 9, 2006
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    GDW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: LAPROSCOPIC CURE OF BILATERAL HERNIA. DEVICES USED: SALUTE HANDLE + SHAFT - 0113036, SERIAL # 3481. DISPOSABLE CARTRIDGE - 0113035, LOT # 43AQD683 & B BRAUN MESH, KRON TYPE. THE SURGEON MADE SEVERAL BLANK TRIALS: NO PROBLEM. DURING THE PROCEDURE, IN ORDER TO MAKE THE FIXATION EASIER WITHIN THE PATIENT, THE SURGEON ASKED THE NURSE TO PRESS THE BRAUN MESH. THE SALUTE DID NOT MAKE A LOOP, INSTEAD, THE NEEDLE WENT COMPLETELY THROUGH THE ABDOMEN AND JABBED INTO THE FINGER OF THE NURSE WHO WAS WEARING 2 PAIRS OF GLOVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SALUTE FIXATION DEVICE ENDOSCOPIC STAPLER & STAPLES GDW DAVOL INC., SUB. C.R. BARD, INC. 43AQD683

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention