BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAPRO MESH

    MDR report key: 3161880 · Received June 11, 2013

    Report

    Report Number
    2210968-2013-10055
    Event Type
    Injury
    Date Received
    June 11, 2013
    Report Date
    June 5, 2013
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K033337
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: (B)(4) 2013.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INCISIONAL HERNIA REPAIR PROCEDURE ON (B)(6) 2012 AND MESH WAS IMPLANTED. ON (B)(6) 2012 THE PATIENT WAS DIAGNOSED WITH A RECURRENT VENTRAL HERNIA AND UNDERWENT SURGERY ON (B)(6) 2012. THE DEFECT WAS REPAIRED WITH SURGIMEND BIOLOGIC MESH. IT WAS NOTED DURING THE SURGERY THAT THE MESH WAS ADHERED TO THE SMALL BOWEL. THE PATIENT DEVELOPED SIGNS OF INFECTION AND BOWEL OBSTRUCTION ON (B)(6) 2012. AN EXPLORATORY LAP WAS PERFORMED. IT WAS NOTED THAT THERE WAS A LEAK AT THE ANASTOMOTIC SITE NEAR THE SMALL BOWEL. THE PATIENT WAS TRANSFERRED TO A LARGER FACILITY AND FOUND TO HAVE (B)(6). THE PATIENT WAS TAKEN INTO SURGERY ON (B)(6) 2012 WHERE A LARGE ENTEROCUTANEOUS FISTULA WITH MULTIPLE INTRA-ABDOMINAL ABSCESSES AND MESH INFECTION WAS DISCOVERED BY THE SURGEON. BOTH SYNTHETIC MESH AND PORCINE MESH WERE FOUND IN THE OPEN WOUND AND AREA OF THE SMALL BOWEL. SHE REQUIRED AN ADDITIONAL SURGERY ON (B)(6) 2012 FOR FURTHER REPAIR OF THE FISTULA AND EXCISE MORE OF THE INFECTED MESH. THE PATIENT WAS HOSPITALIZED UNTIL (B)(6) 2012 AT WHICH TIME SHE WAS TRANSFERRED TO A SKILLED NURSING FACILITY FOR WOUND AND DRAIN MANAGEMENT UNTIL (B)(6) 2012. SHE UNDERWENT ANOTHER SURGERY ON (B)(6) 2013 TO REPAIR THE FISTULA AND THE DOUBLE HERNIA THAT REMAINED UNHEALED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263149 ULTRAPRO MESH MESH, SURGICAL, POLYMERIC FTL ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R