BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SALUTE FIXATION DEVICE

    MDR report key: 638489 · Received August 25, 2005

    Report

    Report Number
    1213643-2005-00153
    Event Type
    Malfunction
    Date Received
    August 25, 2005
    Date of Event
    July 6, 2005
    Report Date
    July 6, 2005
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BROKEN, NOT WORKING. DETERMINED TO PRODUCE STRAIGHT SHOTS 8/2005 - POST EVALUATION OF RGA. RGA 738S. RECEIVED 10/2004.

    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 *