BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH

    MDR report key: 1842383 · Received September 16, 2010

    Report

    Report Number
    2210968-2010-01083
    Event Type
    Injury
    Date Received
    September 16, 2010
    Report Date
    August 16, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - FOUL ODOR - (B)(4) - INFECTION. 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 SURGICAL PROCEDURE FOR A DESMOID TUMOR IN 2008 AND MESH WAS PLACED. IN 2009, THE PT UNDERWENT A SURGICAL PROCEDURE TO REMOVE THE MESH FROM THE ABDOMEN WHICH IS REPORTED TO HAVE SEPARATED AND ATTACHED TO PT'S LIVER. THE PT EXPERIENCED EXTREME PAIN, FOUL ODOR AND SEVERE INFECTION IN THE AFFECTED AREA. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention