BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCEED*SURG MESH/MULTI LYR

    MDR report key: 8517169 · Received April 16, 2019

    Report

    Report Number
    2210968-2019-80016
    Event Type
    Injury
    Date Received
    April 16, 2019
    Report Date
    April 4, 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 · 0

    DATE SENT TO THE FDA: 02/25/2020.

    Additional Manufacturer Narrative · 0

    DATE SENT TO FDA: 8/25/2020.

    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. MWR-(B)(4) SUBMITTED FOR ADVERSE EVENT WHICH OCCURRED ON (B)(6) 2013. MWR-(B)(4) SUBMITTED FOR ADVERSE EVENT WHICH OCCURRED ON (B)(6) 2013.

    Description of Event or Problem · 1

    IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT VENTRAL HERNIA REPAIR SURGERY ON (B)(6) 2008 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY, LYSIS OF ADHESIONS, SMALL BOWEL RESECTION AND EXCISION OF THE PREVIOUSLY PLACED MESH ON (B)(6) 2013 DURING WHICH THE SURGEON NOTED ADHESIONS OF THE SMALL INTESTINE WERE ENCOUNTERED AND TAKEN DOWN. IT WAS REPORTED THAT THE PATIENT UNDERWENT A RECURRENT VENTRAL HERNIA REPAIR SURGERY ON (B)(6) 2013 DURING WHICH THE SURGEON NOTED ADHESIONS OF THE SMALL INTESTINE WERE ENCOUNTERED AND TAKEN DOWN. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN, HERNIA RECURRENCE, BOWEL RESECTION, MESH MIGRATION, NAUSEA, VOMITING, CHILLS, DIARRHEA, INFLAMMATION, ADHESIONS, SCARRING, DISFIGUREMENT, LOSS OF APPETITE AND STRESS AND ANXIETY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313593 PROCEED*SURG MESH/MULTI LYR MESH, SURGICAL, POLYMERIC FTL ETHICON INC. AGG382

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention