BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGIMEND 2.0 10X15 CM

    MDR report key: 10279473 · Received July 15, 2020

    Report

    Report Number
    3004170064-2020-00004
    Event Type
    Malfunction
    Date Received
    July 15, 2020
    Date of Event
    March 16, 2020
    Report Date
    March 16, 2020
    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 · 1

    ROOT CAUSE IS UNDETERMINED. BASED ON THE DHR REVIEW CONDUCTED, THERE IS NO INDICATION THAT THE MANUFACTURING, QUALITY INSPECTIONS OR FINAL PACKAGING/LABELING PROCESSES MAY HAVE CONTRIBUTED TO THIS COMPLAINT. ALL EBM SKINS WERE TESTED AND CHARACTERIZED APPROPRIATELY, AND THE IFU IS CLEAR REGARDING INSTRUCTIONS FOR USE BY THE CLINICIAN. ADDITIONALLY, ALL FINISHED GOODS LOTS MET RAW MATERIAL, IN-PROCESS AND FINISHED GOODS RELEASE ACCEPTANCE CRITERIA FOR ALL REQUIRED INSPECTIONS AND TESTS. THE DEVICE WAS NOT RETURNED FOR FAILURE ANALYSIS. THERE WERE NO ANOMALIES FOUND IN THE DHR REVIEW.

    Description of Event or Problem · 1

    A SURGICAL SALES REPRESENTATIVE REPORTED THAT THE THICKNESS OF THE SURGIMEND WAS ALMOST 3MM THICK INSTEAD OF 2MM. THE PRODUCT WAS USED FOR A SOFT TISSUE REPAIR ON (B)(6) 2020. DURING THE PROCEDURE THEY NOTICED THAT IT WAS DIFFICULT TO SUTURE. NO PATIENT INJURY REPORTED; HOWEVER, THERE WAS A ONE HOUR SURGICAL DELAY DUE TO PRODUCT BEING DIFFICULT TO SUTURE ROBOTICALLY. NO ADVERSE CONSEQUENCE REPORTED DUE TO THE DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745076 SURGIMEND 2.0 10X15 CM SURGIMEND FTM TEI BIOSCIENCES INC 1708021

    Patients

    Seq Age Sex Outcome Treatment
    1