BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROCEED MULTI-LAYER LAMINATE MESH

    MDR report key: 1083683 · Received July 23, 2008

    Report

    Report Number
    2210968-2008-00585
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    June 23, 2008
    Report Date
    June 23, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K060713
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED. THIS REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES, AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA. 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

    INTERNATIONAL CUSTOMER REPORTED THAT THE DEVICE DELAMINATED DURING A VENTRAL INCISIONAL HERNIA REPAIR. THE DEVICE WAS CUT TO SIZE AND NO DAMAGE WAS NOTED PRIOR TO ENTRY INTO THE ABDOMINAL CAVITY. THE DEVICE WAS IN-SITU, EXPOSED TO BLOOD AND MANIPULATED MORE THAN ONE HOUR WHEN THE DEVICE BEGAN TO SEPARATE. THE DEVICE WAS REMOVED AND A SECOND MESH DEVICE WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROCEED MULTI-LAYER LAMINATE MESH MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA ZPG918

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK