BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCLOSE SURGICAL MESH SYSTEM

    MDR report key: 866033 · Received June 15, 2007

    Report

    Report Number
    3005501497-2007-00006
    Event Type
    Injury
    Date Received
    June 15, 2007
    Date of Event
    May 7, 2007
    Report Date
    June 15, 2007
    Manufacturer
    ANULEX TECHNOLOGIES, INC
    Product Code
    FTL
    PMA / PMN Number
    K050969
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. PRODUCTION, PACKAGING AND STERILIZATION RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND. INFECTION IS A KNOWN RISK IN SURGERY OF ANY KIND.

    Description of Event or Problem · 1

    THE INCLOSE-RM MESH WAS IMPLANTED IN 2007 FOLLOWING A DISCECTOMY PROCEDURE FOR TREATMENT OF SYMPTOMS RELATED TO A HERNIATED INTERVERTEBRAL DISC. SIX DAYS LATER, THE PT WAS RE-ADMITTED TO THE HOSPITAL WITH PAIN AND FEVER. SHE UNDERWENT SURGERY ON THE SAME DAY AND CULTURES WERE TAKEN TO CONFIRM INFECTION. THE ORGANISM WAS IDENTIFIED AS STAPHYLOCOCCUS EPIDERMIDIS AND THE PATIENT WAS TREATED WITH ANTIBIOTICS. THE MESH APPEARED TO BE STABLE AND INTEGRATED, SO THE SURGEON ELECTED NOT TO REMOVE IT. THE PATIENT WAS DISCHARGED ON EIGHT DAYS LATER AND SEEN IN THE CLINIC SIX DAYS LATER FOR POST-OPERATIVE FOLLOW UP. HER CONDITION WAS NOTED AS MUCH IMPROVED, MODERATE DECREASE IN PAIN, WITH NO RADICULAR SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INCLOSE SURGICAL MESH SYSTEM SURGICAL MESH, POLYMERIC FTL ANULEX TECHNOLOGIES, INC INCLOSE-RM P070348

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention