BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TUTOPATCH

    MDR report key: 22078211 · Received May 23, 2025

    Report

    Report Number
    3002924436-2025-00014
    Event Type
    Injury
    Date Received
    May 23, 2025
    Report Date
    August 4, 2025
    Manufacturer
    TUTOGEN MEDICAL GMBH (TMI)
    Product Code
    FTM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DESPITE REPEATED INQUIRIES TO THE AUTHOR, THE BATCH DOCUMENTATION COULD NOT BE REVIEWED DUE TO MISSING PRODUCT AND PATIENT DATA. THIS REPORT FROM THE SCIENTIFIC LITERATURE (SAGIRA 2023) REFERS TO THE USE OF BOVINE PERICARDIUM FOR BREAST RECONSTRUCTION. TUTOGEN IDENTIFIED THE BOVINE PERICARDIUM MEMBRANE AS TUTOPATCH. HOWEVER, THIS WAS NOT CONFIRMED BY THE AUTHOR DESPITE SEVERAL FOLLOW-UP ATTEMPTS. FURTHER INFORMATION COULD ALSO NOT BE OBTAINED. FOLLOWING A WORST CASE SCENARIO, THE DESCRIBED BREAST RECONSTRUCTION IS CONSIDERED OFF-LABEL USE FOR TUTOPATCH (123 PATIENTS). INDIVIDUAL PATIENT DATA IS NOT AVAILABLE, AND THE CASE CONSTITUTES A MULTIPLE-PATIENT CASE ALTHOUGH SPECIFIC COMPLICATIONS FOR A SPECIFIC NUMBER OF PATIENTS EACH WERE REPORTED. OFF-LABEL USE IS NOT CONSIDERED SERIOUS. ALL REPORTED COMPLICATIONS ARE CONSIDERED SERIOUS DUE TO REQUIRING MEDICAL INTERVENTIONS (E.G., ANTIBIOTIC TREATMENT OR FURTHER SURGERY), BUT THEY CANNOT BE ASSIGNED TO CERTAIN PATIENTS. THERE WAS NO CAUSALITY ASSESSMENT PROVIDED BY THE AUTHOR. HOWEVER, THE PROVIDED POST-SURGERY COMPLICATIONS ARE CONSIDERED FREQUENT COMPLICATIONS AFTER SURGERY INDEPENDENT OF THE USE OF A PERICARDIUM MEMBRANE. THE COMPLAINT INVOLVES A POTENTIAL OFF-LABEL USE. THEREFORE, THERE IS NO CAUSAL CONNECTION TO THE TUTOPATCH PRODUCT.

    Additional Manufacturer Narrative · 0

    WHEN ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP MED WATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    RTI SURGICAL, INC D/B/A EVERGEN AND TUTOGEN MEDICAL GMBH (TMI), A WHOLLY SUBSIDIARY OF EVERGEN, RECEIVED A COMPLAINT ASSOCIATED WITH AN ARTICLE FOUND THROUGH LITERATURE SEARCH; USE OF BOVINE PERICARDIUM-DERIVED MESH IN DIRECT-TO-IMPLANT RECONSTRUCTION WITH PERMANENT IMPLANT IN THE PTOTIC BREASTS.; TITLE, MEHMET SAGIR; ANNALS OF MEDICAL RESEARCH, 2023, 30 (10): 1200-1204. CONCERNING A STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF THE USE OF BOVINE PERICARDIUM-DERIVED MESH IN THE CREATION OF PREOPERATIVE PTOSIS SIMULATION IN PATIENTS WITH GRADE 1-2-3 PTOSIS IN WHOM SKIN REDUCTION. TECHNIQUES ARE NOT APPLIED AND WHO UNDERWENT MASTECTOMY AND RECONSTRUCTION WITH A PERMANENT IMPLANT. 123 PATIENTS (191 BREASTS) WERE INCLUDED IN THE STUDY. TUTOPATCH WAS THEREFORE USED IN AN OFF-LABEL CONDITION. FOUR PATIENTS DEVELOPED POST-OPERATIVE COMPLICATIONS. -HEMATOMA (PATIENT #2) -RECONSTRUCTION FAILURE (PATIENT #3) -FULL THICKNESS NAC NECROSIS AND SEROMA (PATIENT # 5) -FULL THICKNESS MASTECTOMY FLAP NECROSIS AND INFECTION (PATIENT # 6)3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2366541 TUTOPATCH TUTOPATCH BOVINE PERICARDIUM FTM TUTOGEN MEDICAL GMBH (TMI)

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other