BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCEED MULTI-LAYER LAMINATE MESH

    MDR report key: 729424 · Received June 27, 2006

    Report

    Report Number
    2210968-2006-00447
    Event Type
    Injury
    Date Received
    June 27, 2006
    Report Date
    June 22, 2006
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K031925
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    H-6: NO DEVICE FAILURE REPORTED. [PMA/510(K):K031925].

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A PT DEVELOPED A BOWEL FISTULA RESULTING FROM DIRECT COMMINICATION OF THE BOWEL WITH A DEVICE TACKER USED TO TACK THE MESH DEVICE. THE PT WAS TAKEN BACK TO SURGERY FOR REPAIR OF THE FISTULA. ADHESIONS OF THE BOWEL TO THE DEVICE WERE NOTED. ADHESIOLYSIS WAS PERFORMED AND THE DEVICE EXPLANTED. A PRIMARY CLOSURE WAS PERFORMED. THE PT IS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROCEED MULTI-LAYER LAMINATE MESH MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA UBG624

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention TACKER - NOT SPECIFIED.