BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TUTOPATCH® BOVINE PERICARDIUM

    MDR report key: 20905491 · Received December 11, 2024

    Report

    Report Number
    3002924436-2024-00010
    Event Type
    Injury
    Date Received
    December 11, 2024
    Report Date
    January 22, 2025
    Manufacturer
    TUTOGEN MEDICAL, GMBH
    Product Code
    FTM
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DESPITE SEVERAL FOLLOW-UP ATTEMPTS, NO NEW INFORMATION WAS PROVIDED FROM THE AUTHOR. OFF LABEL USE AND HEMATOMA DEVELOPMENT ARE BOTH CONSIDERED NOT SERIOUS. BOTH EVENTS ARE NOT DESCRIBED IN THE CURRENT IFU FOR THE TUTOPATCH GRAFT. PRODUCT IDENTIFIERS WERE NOT PROVIDED; THEREFORE, A BATCH DOCUMENTATION ANALYSIS COULD NOT BE CONDUCTED. TUTOGEN CONSIDERS THE HEMATOMA DEVELOPMENT EVENT AS BEING RELATED TO THE SURGICAL PROCEDURE AND NOT ASSOCIATED WITH THE TUTOPATCH GRAFT.

    Additional Manufacturer Narrative · 0

    RTI GERMANY'S INVESTIGATION IS IN PROCESS. ONCE THE RESULTS ARE AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    RTI SURGICAL, INC. AND TUTOGEN MEDICAL GMBH (TMI), A WHOLLY SUBSIDIARY OF RTI SURGICAL, CONDUCTED A LITERATURE REVIEW AND FOUND AN ARTICLE PUBLISHED IN THE TURKISH JOURNAL OF MEDICAL SCIENCES, OCTOBER 2024. THE ARTICLE WAS TITLED: COMPARISON OF AUTOLOGOUS VENOUS GRAFTS AND THREE TYPES OF EXTRACELLULAR MATRIX GRAFTS USED IN PEYRONIE'S DISEASE SURGERY. THE PATIENTS UNDERWENT A CORPOROPLASTY WITH PENILE PLICATION AND GRAFTING PROCEDURES BY A SINGLE EXPERIENCED SURGEON BETWEEN 2014 AND 2020 AND WERE RETROSPECTIVELY EVALUATED. A TOTAL OF 115 PATIENTS WERE INCLUDED IN THE STUDY AND DIVIDED INTO 4 GROUPS ACCORDING TO THE GRAFT MATERIAL USED. GROUP 4 REPRESENTED 43 PATIENTS THAT WERE IMPLANTED WITH BOVINE PERICARDIAL EMGS; TUTOPATCH. THE AGE OF THE PATIENTS RANGED FROM 40 TO 64 YEARS OLD. ONE PATIENT, IN GROUP 4, DEVELOPED A HEMATOMA POST-OPERATIVELY. OF NOTE, NO UNIQUE SERIAL IDS OF THE TUTOPATCH® GRAFTS THAT WERE UTILIZED IN THE STUDY WERE DOCUMENTED IN THE ARTICLE. THE TUTOPATCH® GRAFTS WERE USED OFF LABEL. TO DATE, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED TO RTI FOR REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1718641 TUTOPATCH® BOVINE PERICARDIUM TUTOPATCH® FTM TUTOGEN MEDICAL, GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other