BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCEED MULTI-LAYER LAMINATE MESH

    MDR report key: 1212107 · Received October 24, 2008

    Report

    Report Number
    2210968-2008-01042
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    August 16, 2008
    Report Date
    September 24, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K031925
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION CODE: IT IS THE OPINION OF OUR MEDICAL DIRECTOR THAT THE FIBRINOPURULENT PEEL DESCRIBED IN THIS CASE IS TYPICAL OF THAT SEEN WITH PERITONITIS FROM ANY CAUSE. CONTAMINATION MAY HAVE OCCURRED AT THE TIME OF SURGERY. FUNGAL CULTURES SUGGEST A SKIN SOURCE FOR THE CONTAMINATION. NO FURTHER 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

    CUSTOMER REPORTED THAT A PT UNDERWENT A VENTRAL HERNIA REPAIR WITH MESH IMPLANT. THE PT PRESENTED WITH NAUSEA, VOMITING, AND PAIN FOUR DAYS AFTER THE INITIAL SURGERY. THE PT WAS RETURNED TO SURGERY FOR DEVICE EXPLANT, AT WHICH TIME, THE SURGEON OBSERVED A FIBROPURULENT PEEL WITH A BROWN GELATINOUS DISCHARGE UNDERNEATH THE MESH, AND ENCASING THE SMALL BOWEL.

    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 82 YR Required Intervention