BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCEED VENTRAL PATCH

    MDR report key: 2894259 · Received January 3, 2013

    Report

    Report Number
    2210968-2013-00079
    Event Type
    Injury
    Date Received
    January 3, 2013
    Report Date
    December 11, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K061533
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    CONCLUSION: A PORTION OF THE EXCISED MESH WAS RETURNED FOR EVALUATION. THE HISTOLOGICAL EXAMINATION SHOWS AN EXCISED PERITONEUM TISSUE SAMPLE WITH EMBEDDING OF ALLOPLASTIC MESH TISSUE. FURTHER PRESENT ARE MASSIVE SHEET-LIKE FIBROSIS AND DISTINCT CHRONIC INFLAMMATION. NO CONCLUSION OF THE SHRINKING COULD BE DETERMINED BASED ON THE HISTOLOGICAL EXAMINATION OF THE EXCISED TISSUE SAMPLE. ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA REPAIR PROCEDURE ON (B)(6) 2011 AND MESH WAS USED. ON (B)(6) 2012, THE PATIENT RETURNED TO THE DOCTOR WITH SWELLING AND PAIN AT THE HEIGHT OF HIS NAVEL. THE PATIENT WAS DIAGNOSED WITH A RECURRENT UMBILICAL HERNIA. THE PATIENT UNDERWENT A REOPERATION IN (B)(6) 2012. THE SURGEON FOUND THAT THE DEVICE WAS CRIMPED UP. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3118 PROCEED VENTRAL PATCH MESH, SURGICAL, POLYMERICQ FTL ETHICON, INC. NA DL8GKJZ0

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention