BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCEED MULTI-LAYER LAMINATE MESH

    MDR report key: 1910229 · Received November 22, 2010

    Report

    Report Number
    2210968-2010-01544
    Event Type
    Injury
    Date Received
    November 22, 2010
    Report Date
    October 21, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K060713
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A VENTRAL HERNIA REPAIR PROCEDURE ON AN UNK DATE AND MESH WAS PLACED. AT A LATER DATE, THE SURGEON NOTED DENSE ADHESIONS AND THAT THE BOWEL WAS STUCK TO THE MESH. THIS FINDING WAS MADE UPON LAPAROSCOPIC EXAMINATION DURING A SUBSEQUENT AND UNRELATED BILATERAL INGUINAL HERNIA REPAIR. THIS FINDING PROMPTED THE SURGEON TO PERFORM AN OPEN REPAIR OF THE INGUINAL HERNIAS INSTEAD OF A LAPAROSCOPIC REPAIR. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention