BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCEED MULTI-LAYER LAMINATE MESH

    MDR report key: 1102494 · Received August 7, 2008

    Report

    Report Number
    2210968-2008-00685
    Event Type
    Injury
    Date Received
    August 7, 2008
    Date of Event
    July 5, 2008
    Report Date
    July 8, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K060713
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: A PHOTO OF THE EXPLANTED DEVICE WAS EXAMINED. THE PHOTO IMAGE ONLY COVERED A SECTION OF THE DEVICE SO THE SIZE OF THE DEVICE COULD NOT BE DETERMINED. NO ORC COMPONENT IS CLEARLY OBSERVED. THERE IS A SECTION ALONG THE PERIMETER OF THE MESH THAT APPEARS TO BE TORN. THE TORN SITE DID NOT APPEAR TO BE LARGE OR LONG, PERHAPS UP TO 2CM IN SIZE. THE CAUSE AND CIRCUMSTANCES OF THE TEAR COULD NOT BE DETERMINED. 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 PRESENTED WITH AN ASYMETRICAL ABDOMEN FIVE DAYS FOLLOWING AN OPEN INCISIONAL HERNIA REPAIR. THE PATIENT WAS RETURNED TO SURGERY AT WHICH TIME THE SURGEON OBSERVED THAT A PORTION OF THE DEVICE WAS TORN AT TWO SUTURE POINTS. THE DEVICE WAS EXPLANTED AND REPLACED. THE SURGEON OPINES THAT THE EVENT IS RELATED TO EXCESSIVE TENSION PLACED ON THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROCEED MULTI-LAYER LAMINATE MESH MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA ZGG410

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention SUTURES - NYLON