BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARIETEX COMPOSITE

    MDR report key: 571711 · Received February 9, 2005

    Report

    Report Number
    9615742-2005-00001
    Event Type
    Injury
    Date Received
    February 9, 2005
    Date of Event
    December 16, 2004
    Report Date
    February 4, 2005
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 2005 SOFRADIM (MANUFACTURER) WAS INFORMED BY DISTRIBUTOR OF A ADVERSE EVENT FOLLOWING THE IMPLANTATION VIA OPEN SURGERY OF A PARIETEX COMPOSITE MESH: THE MESH WAS IMPLANTED ON THE AND HAD TO BE EXPLANTED ONE DAY AFTER FOR EARLY RECURRENCE. DR. OPENED THE PT AND SAID THAT THE MESH APPEARED TORN. THE EXPLANTED MESH WAS RETURNED TO SOFRADIM PRODUCTION FOR EXAMINATION IN 2005.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARIETEX COMPOSITE SURGICAL MESH FTL SOFRADIM PRODUCTION PCO1510 B22101PCO15

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention