BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROCEED MULTI-LAYER LAMINATE MESH

    MDR report key: 1060708 · Received June 5, 2008

    Report

    Report Number
    2210968-2008-00408
    Event Type
    Malfunction
    Date Received
    June 5, 2008
    Date of Event
    May 6, 2008
    Report Date
    May 7, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K060713
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE DELAMINATION. 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 ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE EDGE OF THE DEVICE DELAMINATED DURING IMPLANT. THE SURGEON HAD CUT THE DEVICE PRIOR TO IMPLANT. THE DELAMINATED PORTION OF THE DEVICE WAS TACKED IN PLACE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROCEED MULTI-LAYER LAMINATE MESH MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA ABG097

    Patients

    Seq Age Sex Outcome Treatment
    1