BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SALUTE FIXATION DEVICE

    MDR report key: 777063 · Received August 25, 2006

    Report

    Report Number
    1213643-2006-00246
    Event Type
    Malfunction
    Date Received
    August 25, 2006
    Date of Event
    July 26, 2006
    Report Date
    August 25, 2006
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT PRODUCT HAS BEEN RECEIVED AND IS STILL OUT FOR EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF EVALUATION.

    Description of Event or Problem · 1

    STRAIGHT SHOTS. DISCOVERED DURING TEST FIRE. REC'D 08/23/2005.

    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 *