BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGIMEND MATRIX - UNSPECIFIED

    MDR report key: 17302673 · Received July 11, 2023

    Report

    Report Number
    3004170064-2023-00012
    Event Type
    Injury
    Date Received
    July 11, 2023
    Report Date
    August 9, 2023
    Manufacturer
    TEI BIOSCIENCES INC
    Product Code
    FTM
    PMA / PMN Number
    K171357
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE SURGIMEND (ID UNKNOWN) WAS NOT RETURNED FOR EVALUATION AND LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED. THE ROOT CAUSE(S) OF THE REPORTED ISSUE 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.

    Additional Manufacturer Narrative · 0

    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 · 0

    N/A.

    Description of Event or Problem · 0

    A FACILITY REPORTED A PATIENT WHO HAD A VENTRAL HERNIA REPAIRED WITH SURGIMEND MP WAS READMITTED TO THE HOSPITAL WITH FEVER 3 WEEKS AFTER SURGERY. THIS PATIENT WAS DIAGNOSED WITH PNEUMONIA, AND THEREFORE, SHE BELIEVES THAT THE FEVER WAS RELATED TO PNEUMONIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233108 SURGIMEND MATRIX - UNSPECIFIED N/A FTM TEI BIOSCIENCES INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown