BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCEED* MULTI-LAYER LAMINATE MESH

    MDR report key: 2933443 · Received January 29, 2013

    Report

    Report Number
    2210968-2013-00642
    Event Type
    Injury
    Date Received
    January 29, 2013
    Report Date
    January 8, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INCARCERATED VENTRAL HERNIA REPAIR THREE YEARS AGO AND MESH WAS IMPLANTED. THE SURGEON STATED THAT THE IMPLANTING SURGEON PLACED THE MESH EVEN THOUGH THERE WAS AN INFECTION. SINCE THE SURGERY, THE PATIENT HAS HAD A FOUL SMELLING ODOR AND DISCHARGE FROM THE NAVAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39006 PROCEED* MULTI-LAYER LAMINATE MESH MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention