BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCEED* MULTI-LAYER LAMINATE MESH

    MDR report key: 3092369 · Received May 3, 2013

    Report

    Report Number
    2210968-2013-04947
    Event Type
    Injury
    Date Received
    May 3, 2013
    Report Date
    August 7, 2019
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K060713
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE IN ORDER TO TREAT A BOWEL OBSTRUCTION ON (B)(6) 2005 AND MESH WAS IMPLANTED. THE PATIENT REQUIRED ADDITIONAL SURGERY IN (B)(6) 2011 AND (B)(6) 2011 IN ORDER TO TREAT AN INFECTION AND UNSPECIFIED COMPLICATION CAUSED BY THE DISINTEGRATION OF THE MESH. NO ADDITIONAL INFORMATION WAS PROVIDED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). UNSPECIFIED COMPLICATIONS. INFECTION. 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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DATE SENT TO FDA: 8/12/2019. (B)(4). ADDITIONAL NARRATIVE: IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON 5/8/2015 DURING WHICH THE SURGEON NOTED ¿UPON VISUALIZING THE MESH, CONCERNS OF A SUBCLINICAL INFECTION NECESSITATED THE DISSECTION AND SHARP EXCISION OF THE MESH.¿ IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN AND INFLAMMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SURGICAL PROCEDURE TO A BOWEL OBSTRUCTION IN (B)(6) 2005 AND MESH WAS IMPLANTED. THE PATIENT REQUIRED ADDITIONAL SURGERY IN (B)(6) 2011 AND (B)(6) 2011 TO TREAT AN INFECTION AND UNSPECIFIED COMPLICATION CAUSED BY THE DISINTEGRATION OF THE MESH. NO ADDITIONAL INFORMATION WAS PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194751 PROCEED* MULTI-LAYER LAMINATE MESH MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA BHG341

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention