BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SALUTE FIXATION DEVICE

    MDR report key: 897478 · Received October 18, 2004

    Report

    Report Number
    1213643-2004-00094
    Event Type
    Malfunction
    Date Received
    October 18, 2004
    Date of Event
    July 22, 2004
    Report Date
    July 22, 2004
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FIRING INCORRECTLY. ORIGINALLY CALLED IN AS A STANDARD RGA. DETERMINED TO BE STRAIGHT SHOTS AFTER EVALUATION. DETERMINED TO BE MDR ON 09/22/2004.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *