BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SALUTE FIXATION DEVICE

    MDR report key: 693563 · Received March 29, 2006

    Report

    Report Number
    1213643-2006-00076
    Event Type
    Malfunction
    Date Received
    March 29, 2006
    Date of Event
    February 13, 2006
    Report Date
    February 27, 2006
    Manufacturer
    DAVOL INC., SUB C.R. BARD, INC.
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INITIALLY REPORTED ON 2/13/2006 "COLLAR TO SHAFT BENT" DETERMINED TO BE REPORTABLE IN 2006 - WIRE IN TIP/STRAIGHT SHOTS.

    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. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *