BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGIMEND 3.0 13X25 CM

    MDR report key: 8431932 · Received March 19, 2019

    Report

    Report Number
    3004170064-2019-00007
    Event Type
    Malfunction
    Date Received
    March 19, 2019
    Report Date
    January 31, 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 · 1

    ROOT CAUSE IS INDETERMINABLE. THE DEVICE WAS NOT RETURNED FOR FAILURE ANALYSIS. THERE WERE NO ANOMALIES FOUND IN THE DHR REVIEW. BASED ON THE DHR REVIEW CONDUCTED, THERE IS NO INDICATION THAT THE MANUFACTURING OR FINAL PACKAGING/LABELING PROCESSES MAY HAVE CONTRIBUTED TO THIS COMPLAINT.

    Description of Event or Problem · 1

    A SALES REPRESENTATIVE REPORTED THAT SURGIMEND (ID (B)(6)) DISSOLVED AFTER IMPLANTATION. NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER SEVERAL ATTEMPTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225866 SURGIMEND 3.0 13X25 CM SURGIMEND FTM TEI BIOSCIENCES INC 1804009

    Patients

    Seq Age Sex Outcome Treatment
    1