BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCEED* MULTI-LAYER LAMINATE MESH

    MDR report key: 3060138 · Received April 16, 2013

    Report

    Report Number
    2210968-2013-03954
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    March 27, 2013
    Report Date
    March 27, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K060713
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED HAS BEEN RECEIVED, HOWEVER, THE PRODUCT EVALUATION IS NOT YET COMPLETE. ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Additional Manufacturer Narrative · 1

    CONCLUSION: THREE RETURNED SECTIONS OF EXPLANTED MESH WERE VISUALLY EXAMINED. THE RETURNED EXPLANTED MESH HAD ENCAPSULATING TISSUE ON EITHER SIDE OF THE MESH, COMPLETELY OBSCURING IT, EXCEPT AT THE CUT SECTIONS. THE ENCAPSULATED EXPLANTED MESH APPEARED CONSISTENT WITH A FOREIGN BODY REACTION. NO ANOMALIES OR DEFECTS WITH THE PRODUCT WERE OBSERVED. 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 A VENTRAL HERNIA REPAIR PROCEDURE ON (B)(6) 2012 AND MESH WAS IMPLANTED. THE PATIENT RETURNED TO SURGERY ON (B)(6) 2013 FOR REMOVAL OF THE MESH DUE TO A POSSIBLE SEROMA. DURING THE PROCEDURE, A COLLECTION OF FLUID AND TISSUE WAS FOUND BETWEEN THE LAYERS OF MESH. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162862 PROCEED* MULTI-LAYER LAMINATE MESH MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA DLG292

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention