BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROCEED MULTI-LAYER LAMINATE MESH

    MDR report key: 1934434 · Received December 3, 2010

    Report

    Report Number
    2210968-2010-01651
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 4, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K060713
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADD'L INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT AN OPEN VENTRAL HERNIA REPAIR PROCEDURE ON (B)(6)2010. DURING THE PROCEDURE, DELAMINATION OF ONE CORNER OF THE MESH WAS NOTED WHEN FIXATION WAS 3/4 OF THE WAY COMPLETED. THE SURGEON CONTINUED TO IMPLANT THE MESH AND SUTURE THE MESH IN PLACE. THERE WERE NO ADVERSE PT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROCEED MULTI-LAYER LAMINATE MESH MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA CJG405

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK