BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCEED VENTRAL PATCH

    MDR report key: 1392889 · Received May 22, 2009

    Report

    Report Number
    2210968-2009-00591
    Event Type
    Injury
    Date Received
    May 22, 2009
    Report Date
    April 21, 2009
    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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 05/21/2009. ADHESION OCCURRED. 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'S BOWEL BECAME ATTACHED TO THE ORC SIDE OF THE MESH. NO OTHER INFO IS KNOWN AT THIS TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention