BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PVP MEDIUM 6.4CM X 6.4CM

    MDR report key: 8685995 · Received June 11, 2019

    Report

    Report Number
    2210968-2019-82287
    Event Type
    Injury
    Date Received
    June 11, 2019
    Report Date
    June 3, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    UDI-DI
    10705031132405
    PMA / PMN Number
    K061533
    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 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 INCISIONAL HERNIA REPAIR SURGERY ON (B)(6) 2009 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REPAIR OF A RECURRENT VENTRAL INCISIONAL HERNIA REPAIR SURGERY ON (B)(6) 2015 DURING WHICH THE SURGEON NOTED THE OLD MESH HAD SHRUNKEN SIGNIFICANTLY AND WAS VERY SMALL IN SIZE. THE OLD MESH WAS EXCISED FROM THE ANTERIOR ABDOMINAL WALL. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN, ADHESIONS, NAUSEA, CHILLS, INFLAMMATION, LOSS OF APPETITE, STRESS AND ANXIETY. NO ADDITIONAL INFORMATION IS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482258 PVP MEDIUM 6.4CM X 6.4CM MESH, SURGICAL, POLYMERIC FTL ETHICON INC. AM9JGGZ0 10705031132405

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention