BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCEED*SURG MESH/MULTI LYR

    MDR report key: 8547980 · Received April 25, 2019

    Report

    Report Number
    2210968-2019-80367
    Event Type
    Injury
    Date Received
    April 25, 2019
    Report Date
    April 11, 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 INFORMATION: D3,G1,G2. CORRECTED INFORMATION: G1.

    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. IN ADDITION, A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND INDICATES THAT THERE WERE NO QUALITY CONCERNS ASSOCIATED WITH THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A RECURRENT VENTRAL HERNIA REPAIR SURGERY ON (B)(6) 2012 AND MESH WAS IMPLANTED DURING WHICH THE SURGEON NOTED THE PREVIOUSLY PLACED MESH WAS NOTED TO BE ADHERENT TO THE OMENTUM INTO A PORTION OF THE TRANSVERSE COLON. THE MESH WAS DISSECTED AWAY AND REMOVED. IT WAS REPORTED THAT THE PATIENT UNDERWENT A RECURRENT VENTRAL INCISIONAL HERNIA REPAIR SURGERY ON (B)(6) 2015 DURING WHICH THE ADHESIONS TO THE PREVIOUSLY PLACED MESH WERE NOTED AND TAKEN DOWN. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN, HERNIA RECURRENCE, ADHESIONS, NAUSEA, INFLAMMATION, SCARRING, DISFIGUREMENT, LOSS OF APPETITE, STRESS AND ANXIETY. THE PATIENT HAD A PREVIOUS MESH IMPLANTED ON (B)(6) 2009 WHICH IS CAPTURED IN SEPARATE FILES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344502 PROCEED*SURG MESH/MULTI LYR MESH, SURGICAL, POLYMERIC FTL ETHICON INC. DKG256

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention