BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCEED VENTRAL PATCH

    MDR report key: 1903403 · Received November 12, 2010

    Report

    Report Number
    2210968-2010-01504
    Event Type
    Injury
    Date Received
    November 12, 2010
    Report Date
    October 12, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K061533
    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). RECURRENT HERNIA. CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADD'L INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT AN OPEN UMBILICAL HERNIA REPAIR PROCEDURE ON AN UNK DATE AND MESH WAS USED. THE PT EXPERIENCED A RECURRENT HERNIA AND HAD A LAPAROSCOPIC REOPERATION ON (B)(6) 2010. THE INITIAL MESH WAS INCORPORATED, SO IT REMAINS IN PLACE. NO ADD'L INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention