BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCEED* MULTI-LAYER LAMINATE MESH

    MDR report key: 2060183 · Received April 15, 2011

    Report

    Report Number
    2210968-2011-00434
    Event Type
    Injury
    Date Received
    April 15, 2011
    Report Date
    March 24, 2011
    Manufacturer
    ETHICON
    Product Code
    FTL
    PMA / PMN Number
    K060713
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A PRIMARY VENTRAL LAPAROSCOPIC HERNIA REPAIR ON (B)(6) 2010 AND MESH WAS IMPLANTED. THE PATIENT DEVELOPED A RECURRENT VENTRAL HERNIA ON AN UNKNOWN DATE. ON (B)(6) 2011, THE PATIENT HAD A SECOND SURGERY. DURING THIS PROCEDURE, THE PHYSICIAN NOTED THAT THE RIGHT SIDE OF THE MESH, TACKS HAD PULLED AWAY FROM PERITONEAL WALL, LODGING THE MESH INTO THE HERNIA DEFECT. THE MESH WAS INCORPORATED INTO THE BOWEL. THE PHYSICIAN WAS ABLE TO REMOVE THE MESH FROM THE BOWEL WITHOUT RESECTING THE BOWEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROCEED* MULTI-LAYER LAMINATE MESH MESH, SURGICAL, POLYMERIC FTL ETHICON NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PROTACK