BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCEED MULTI-LAYER LAMINATE MESH

    MDR report key: 1192785 · Received October 8, 2008

    Report

    Report Number
    2210968-2008-00970
    Event Type
    Injury
    Date Received
    October 8, 2008
    Date of Event
    September 6, 2008
    Report Date
    September 10, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K060713
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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 ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT DEVELOPED A BOWEL ANASTOMOTIC RUPTURE APPROXIMATELY 12 HOURS FOLLOWING BOWEL PROCEDURE. SURGICAL MESH WAS USED TO CLOSE THE ABDOMEN FOLLOWING THE ORIGINAL BOWEL PROCEDURE. THE PATIENT WAS TAKEN TO SURGERY TO ADDRESS THE ANASTOMOTIC LEAK AT WHICH TIME THE SURGEON OBSERVED THAT THE ORC LAYER HAD DELAMINATED FROM THE MESH. THE MESH WAS EXPLANTED DUE TO THE DELAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROCEED MULTI-LAYER LAMINATE MESH MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA AAG038

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention