BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE HERNIA SYSTEM

    MDR report key: 1141051 · Received August 29, 2008

    Report

    Report Number
    2210968-2008-00751
    Event Type
    Injury
    Date Received
    August 29, 2008
    Date of Event
    June 5, 2008
    Report Date
    July 29, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K984220
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION CODE: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADD'L INFO BE OBTAINED, A SUPPLEMENTAL 3500 FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT THE PT PRESENTS WITH CHRONIC DEBILITATING PAIN WITH FEVER AND CHILLS FOLLOWING AN INGUINAL HERNIA REPAIR WITH MESH IMPLANT. THE PT WAS PRESCRIBED ANTIBIOTICS AND PAIN MEDICATION. A CT-SCAN REVEALED A FLUID COLLECTION AT THE LEVEL OF THE ILIAC VESSELS. THE FLUID WAS ASPITATED UNDER CT GUIDANCE. THE FLUID COLLECTION IS OPINED TO BE A SPERMATOCOEL. THE SURGEON REPORTS NO CAUSAL RELATIONSHIP BETWEEN THE PT EVENTS AND THE DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention