BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGIMEND 2.0 25X40 CM

    MDR report key: 10785955 · Received November 4, 2020

    Report

    Report Number
    3004170064-2020-00010
    Event Type
    Malfunction
    Date Received
    November 4, 2020
    Report Date
    March 29, 2021
    Manufacturer
    TEI BIOSCIENCES INC
    Product Code
    FTM
    PMA / PMN Number
    K083898
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE HISTORY RECORD: THERE WERE NO ANOMALIES FOUND AND THERE IS NO INDICATION THAT THE MANUFACTURING OR FINAL PACKAGING/LABELING PROCESSES MAY HAVE CONTRIBUTED TO THIS COMPLAINT. ADDITIONALLY, ALL FINISHED GOODS LOTS RELEASED TO THE MARKET BY INTEGRA LIFESCIENCES MEET ACCEPTANCE CRITERIA FOR ALL REQUIRED INSPECTIONS AND TESTS. EVALUATION OF THE PRODUCT SAMPLE CANNOT BE PERFORMED DUE TO THE STATE OF THE RETURNED PRODUCT, SURGIMEND (PRODUCT ID 606200016). THE HYDRATED DEVICE CANNOT BE ANALYZED DUE TO THE STRUCTURAL CHANGES CAUSED BY HYDRATION AND TIME LAPSE DURING TRANSIT (GELATIN-LIKE DEVICE CONSISTENCY). AS ENTIRE DEVICE LOT MET ALL ACCEPTANCE RELEASE CRITERIA, POSSIBLE CAUSES OF FAILURE ARE AS FOLLOWS: DEVICE NOT HYDRATED AT ROOM TEMPERATURE (WARM/HOT SALINE); DO NOT EXPOSE TO CHEMICALS OR SUBSTANCES OTHER THAN STERILE, ROOM TEMPERATURE 0.9% SALINE. EXCESSIVE HEAT CAN DAMAGE COLLAGEN. DO NOT HYDRATE IN 0.9% SALINE WARMED ABOVE ROOM TEMPERATURE. IF, WHEN HYDRATED, THE PRODUCT SHRINKS IN SIZE, DO NOT USE THE PRODUCT. COMPLAINT INVESTIGATION (FAILURE ANALYSIS) AND DETERMINATION OF ROOT CAUSE IS NOT POSSIBLE AS THE COMPLAINT COULD NOT BE VERIFIED DUE TO THE PRODUCT SAMPLE MEETING SPECIFICATION REQUIREMENTS.

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED THE SURGIMEND WAS USED FOR AN ABR (ABDOMINAL WALL RECONSTRUCTION), IT WAS HYDRATED IN HEATED SALINE WITH BACITRACIN, FOR ABOUT 3-5 MIN THEN PLACED IN PATIENT. THE SURGIMEND WAS PLACED IN ABDOMINAL CAVITY AND BEGAN SURGICAL PROCEDURE AND APPROXIMATELY 45 MINUTES LATER, AS SURGEONS WERE FINISHING UP PLACING MESH, MESH STARTED TEARING. THE PROCEDURE WAS SUBSTANTIALLY LONGER AS A RESULT OF THE MESH TEARING, SOMEWHERE IN THE 1.5 TO 2 HOUR RANGE, AS IT HAD TO BE REMOVED AND REPLACED WITH A NEW PIECE. BECAUSE IT WAS DISCOVERED PRIOR TO COMPLETING THE CASE, WE WERE ABLE TO REPLACE THE MESH WITHOUT ANY ADVERSE OUTCOME TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1251730 SURGIMEND 2.0 25X40 CM SURGIMEND FTM TEI BIOSCIENCES INC 1903026

    Patients

    Seq Age Sex Outcome Treatment
    1