BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCEED* MULTI-LAYER LAMINATE MESH

    MDR report key: 2834224 · Received November 15, 2012

    Report

    Report Number
    2210968-2012-07355
    Event Type
    Injury
    Date Received
    November 15, 2012
    Report Date
    October 24, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K060713
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: 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

    IT WAS REPORTED BY A FAMILY MEMBER OF THE PATIENT THAT SHE UNDERWENT AN UMBILICAL HERNIA REPAIR IN (B)(6) 2010 AND MESH WAS USED. DURING THE PROCEDURE SHE ALSO HAD A TUMMY TUCK. SINCE THE SURGERY SHE HAS HAD FIFTEEN ADDITIONAL SURGERIES. SHE ALSO HAS HAD MRSA AND SEPSIS. THE WOUND IS NOT HEALING AND THE TUNNELING IS OCCURRING CREATING NEW WOUNDS. THE PATIENT HAS BEEN BEDRIDDEN FOR TWO YEARS. THE CALLER REPORTS THE SURGEON DOES NOT FEEL IT IS MESH RELATED AND WILL NOT REMOVE THE MESH. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROCEED* MULTI-LAYER LAMINATE MESH MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA CGG307

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention