BEUDAMED
    FDA Adverse Event Summary report: N

    DURA-GUARD

    MDR report key: 3853102 · Received May 6, 2014

    Report

    Report Number
    3853102
    Date Received
    May 6, 2014
    Date of Event
    April 16, 2014
    Report Date
    May 6, 2014
    Manufacturer
    SYNOVIS LIFE TECHNOLOGIES, INC.
    Product Code
    GXQ
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE IMPLANT STICKERS THAT WERE LOCATED ON THE INSIDE OF THE BOX WERE FOR A DIFFERENT PRODUCT (SYNOVIS VASCU-GUARD) THAN WHAT WAS INDICATED ON THE OUTSIDE OF THE BOX (SYNOVIS DURA-GUARD). THE STICKERS ON THE OUTSIDE OF THE BOX WERE FOR THE ACCURATE PRODUCT. NO HARM TO PATIENT. CORRECT PRODUCT WAS USED. COULD HAVE CAUSED A DELAY IF THE INCORRECT PRODUCT WAS IN THE BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272127 DURA-GUARD DURA SUBSTITUTE GXQ SYNOVIS LIFE TECHNOLOGIES, INC. DG-1016SN *

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR