BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCEED VENTRAL PATCH

    MDR report key: 2120587 · Received June 10, 2011

    Report

    Report Number
    2210968-2011-00746
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 18, 2011
    Manufacturer
    ETHICON
    Product Code
    FTL
    PMA / PMN Number
    K061533
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LIMITED TISSUE INGROWTH. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INCONCLUSIVE - THE EXPLANTED MESH SHOWED THE NON-RESORBABLE, LARGE PORE, MONOFILAMENT POLYPROPYLENE MESH WHICH SHOWS MINIMAL PERSISTING FOREIGN BODY REACTION WITH MINIMAL FIBROSIS. CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN UMBILICAL HERNIA REPAIR ON (B)(6), 2011 AND MESH WAS USED. AFTER THE PROCEDURE, THE PATIENT DEVELOPED A NEW HERNIA IN THE EPIGASTRIC AREA DUE TO AN ASTHMA ATTACK AND A LARGE BOUT OF COUGHING. DURING THE LAPROSCOPIC PROCEDURE ON (B)(6), 2011 TO FIX THE EPIGASTRIC HERNIA, THE SURGEON FOUND THAT THE MESH USED ON THE UMBILICAL HERNIA HAD LIMITED TISSUE INGROWTH AND SMALL ADHESIONS. THE SURGEON REMOVED THE MESH THAT WAS USED ON THE UMBILICAL HERNIA AND REPAIRED THAT HERNIA WITH PHYSIOMESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROCEED VENTRAL PATCH MESH, SURGICAL, POLYMERIC FTL ETHICON NA CA8LQRZ0

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention