BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCEED MULTI-LAYER LAMINATE MESH

    MDR report key: 728759 · Received June 26, 2006

    Report

    Report Number
    2210968-2006-00445
    Event Type
    Injury
    Date Received
    June 26, 2006
    Report Date
    January 15, 2006
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K031925
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    H6: CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. 510K#:K031925.

    Description of Event or Problem · 1

    SURGEON REPORTS THAT THE PATIENT'S BOWEL WAS FOUND TO BE COMPLETELY ADHERED TO THE PLOYPROPYLENE LAYER OF PROCEED MESH APPROXIMATELY 4 MONTHS POST IMPLANTATION. THE PATIENT DEVELOPED A BOWEL FISTULA AND SUBSEQUENT INFECTION. THE PATIENT WAS RETURNED TO SURGERY WHERE THE MESH WAS EXCISED AND REPLACED WITH A COMPETITIVE PRODUCT. THE PATIENT IS REPORTED AS WELL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention