BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGIMEND E3.0 10CM X 25CM

    MDR report key: 8524033 · Received April 17, 2019

    Report

    Report Number
    3004170064-2019-00008
    Event Type
    Malfunction
    Date Received
    April 17, 2019
    Report Date
    March 21, 2019
    Manufacturer
    TEI BIOSCIENCES INC
    Product Code
    FTM
    PMA / PMN Number
    K083898
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DHR; THERE IS NO INDICATION THAT THE MANUFACTURING OR FINAL PACKAGING/LABELING PROCESSES MAY HAVE CONTRIBUTED TO THIS COMPLAINT. ROOT CAUSE IS INDETERMINABLE. THE DEVICE WAS NOT RETURNED FOR FAILURE ANALYSIS.

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 3 DAYS AFTER INCISIONAL HERNIA REPAIR (POST KIDNEY TRANSPLANT) IN THE RIGHT LATERAL ABDOMEN, THERE WAS HOLES IN THE MESH AND WAS EASILY PULLED APART IN TO STRINGY SUBSTANCE. INFECTION MAY HAVE BEEN A POSSIBILITY, BUT CERTAINLY NOT CLINICALLY SIGNIFICANT AND NOT EVIDENT IN CULTURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316214 SURGIMEND E3.0 10CM X 25CM SURGIMEND FTM TEI BIOSCIENCES INC 1706047

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR