BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCEED*SURG MESH/MULTI LYR

    MDR report key: 8765010 · Received July 5, 2019

    Report

    Report Number
    2210968-2019-83108
    Event Type
    Injury
    Date Received
    July 5, 2019
    Report Date
    June 20, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K060713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE, THE DEVICE HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED FOR EVALUATION, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. IN ADDITION, A DEVICE HISTORY REVIEW HAS BEEN INSERTED INTO THE FILE. THIS REVIEW INDICATES THAT THERE WAS NO QUALITY CONCERNS ASSOCIATED WITH THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT INCISIONAL HERNIA REPAIR SURGERY ON (B)(6) 2017 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT AN APPENDECTOMY ON (B)(6) 2017. IT WAS REPORTED THAT THE PATIENT UNDERWENT INCISIONAL HERNIA REPAIR SURGERY ON (B)(6) 2017 DURING WHICH THE SURGEON NOTED DIFFUSE ADHESIONS TO THE PREVIOUS MIDLINE HERNIA REPAIR, WHICH WERE LYSED. IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL ABDOMINAL COLECTOMY AND ILEOSTOMY ON AN UNKNOWN DATE DURING WHICH THE SURGEON NOTED EXTENSIVE ADHESIONS TO THE PREVIOUSLY PLACED MESH. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN, DENSE ADHESIONS, NAUSEA, CHILLS, INFLAMMATION, SCARRING, DISFIGUREMENT, LOSS OF APPETITE, STRESS AND ANXIETY. THE PATIENT HAD A PREVIOUS MESH IMPLANTED ON (B)(6) 2016 WHICH IS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557085 PROCEED*SURG MESH/MULTI LYR MESH, SURGICAL, POLYMERIC FTL ETHICON INC. LEG230

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention