BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SALUTE FIXATION DEVICE

    MDR report key: 584658 · Received March 17, 2005

    Report

    Report Number
    1213643-2005-00032
    Event Type
    Malfunction
    Date Received
    March 17, 2005
    Date of Event
    February 22, 2005
    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

    STRAIGHT SHOTS. SALESMAN HAD TWO SETS -0113036 AND 0113037. HE HAD BEEN USING THEM AS MISMATCHED SERIAL NUMBERS.

    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 *