BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SALUTE FIXATION DEVICE

    MDR report key: 720345 · Received July 21, 2005

    Report

    Report Number
    1213643-2005-00123
    Event Type
    Malfunction
    Date Received
    July 21, 2005
    Date of Event
    March 18, 2005
    Report Date
    June 22, 2005
    Manufacturer
    *
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    STRAIGHT SHOTS. INITIALLY REPORTED IN 3/2005 AS RGA - "SHIPPED IN ERROR." DETERMINED TO BE STRAIGHT SHOTS IN 06/2005.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SALUTE FIXATION DEVICE ENDOSCOPIC STAPLER & STAPLES GDW * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *