BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGIMEND MATRIX - UNSPECIFIED

    MDR report key: 10826181 · Received November 11, 2020

    Report

    Report Number
    3004170064-2020-00013
    Event Type
    Injury
    Date Received
    November 11, 2020
    Report Date
    March 26, 2021
    Manufacturer
    TEI BIOSCIENCES INC
    Product Code
    FTM
    PMA / PMN Number
    K171357
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SURGIMEND WAS NOT RETURNED FOR EVALUATION (REMAINS IMPLANTED) AND LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND MANUFACTURING RECORDS COULD NOT BE REVIEWED. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    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

    PATIENT 3: A FACILITY REPORTED THE PATIENT DEVELOPED HYPERSENSITIVITY AFTER SURGIMEND PLACEMENT. NO ADDITIONAL INFORMATION AVAILABLE. 3 OF 6 REPORTS: SAME EVENT, DIFFERENT PATIENTS. OTHER MFG REPORT NUMBERS: 3004170064-2020-00011, 3004170064-2020-00012, 3004170064-2020-00014, 3004170064-2020-00015, AND 3004170064-2020-00016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1290603 SURGIMEND MATRIX - UNSPECIFIED N/A FTM TEI BIOSCIENCES INC

    Patients

    Seq Age Sex Outcome Treatment
    1