BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGIMEND

    MDR report key: 4359799 · Received December 17, 2014

    Report

    Report Number
    3004170064-2014-00283
    Event Type
    Injury
    Date Received
    December 17, 2014
    Report Date
    December 15, 2014
    Manufacturer
    TEI BIOSCIENCES INC.
    Product Code
    FTM
    PMA / PMN Number
    071807
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD FOR THIS DEVICE WAS REVIEWED AND EVERYTHING WAS IN ORDER.

    Description of Event or Problem · 1

    EXPLORATORY SURGERY WAS SCHEDULED FOR (B)(6) 2014 FOLLOWING A PRIOR ABDOMINAL SURGERY IN (B)(6) 2014. AT THE TIME OF THE EXPLORATORY SURGERY, THE SURGEON NOTED THAT THE PT'S ABDOMEN WAS "NASTY" AND THE COLON WAS INFECTED. THE SURGEON PERFORMED AN INGUINAL REPAIR WHERE THE SURGIMEND DEVICE WAS IMPLANTED ON (B)(6) 2014. ON (B)(6) 2014, IT WAS NOTED THAT THE DEVICE HAD PARTIALLY DISINTEGRATED. THE MARGINS WERE STILL INTACT, BUT THE ENTIRE BODY OF THE DEVICE HAD DISRUPTED. AT THAT POINT THE SURGEON ELECTED TO IMPLANT A SECOND DEVICE. THERE HAVE BEEN NO ISSUES WITH THE SECOND DEVICE. THE SURGEON INDICATED THE PT HAD AN INFECTION IN A CONTAMINATED SURGICAL FIELD. IT IS NOT KNOWN IF THE FIRST DEVICE HAS BEEN EXPLANTED. IT IS NOT KNOWN WHAT THE PT'S CURRENT CONDITION IS. IT IS PROBABLE THAT THE PT'S CONDITION (CONTAMINATION/INFECTION) CONTRIBUTED/CAUSED THE DEVICE TO FAIL. THE DEVICE INSTRUCTIONS FOR USE CAUTION AGAINST USE OF THE DEVICE IN AN INFECTED SURGICAL LOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829210 SURGIMEND SURGICAL MESH FTM TEI BIOSCIENCES INC. 606-001-004 1304003

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| L| O