BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SALUTE FIXATION DEVICE

    MDR report key: 686058 · Received September 2, 2005

    Report

    Report Number
    1213643-2005-00162
    Event Type
    Malfunction
    Date Received
    September 2, 2005
    Date of Event
    July 26, 2005
    Report Date
    July 26, 2005
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    STRAIGHT SHOTS. INITIALLY REPORTED IN 2005 AS A BROKEN TIP. DETERMINED TO BE MDR REPORTABLE AS STRAIGHT SHOTS ABOUT TWO WEEKS LATER ON 08/08/2005. RECEIVED ABOUT SEVEN MONTHS EARLIER 01/04/2005.

    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 *