BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGIMESH

    MDR report key: 2212698 · Received April 12, 2011

    Report

    Report Number
    3005841068-2011-00002
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    March 18, 2011
    Report Date
    April 8, 2011
    Manufacturer
    ASPIDE MEDICAL
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT EXPERIENCED A RECURRENCE WHICH DR. (B)(6) RE-OPERATED ON AND FOUND A SEPARATION AT THE EDGE OF THE SURGIMESH; DR. (B)(6) ELECTED TO REMOVE THE ORIGINAL SURGIMESH AND REPLACE IT WITH A LARGER SURGIMESH XB E-1522; NO BROKEN SUTURES WERE NOTED AND NO TEARS SEEN IN THE TISSUE OR THE REMOVED SURGIMESH SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGIMESH TINTRA XB FTL ASPIDE MEDICAL C10 F03956A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention