BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TUTOMESH

    MDR report key: 21575363 · Received March 11, 2025

    Report

    Report Number
    3002924436-2025-00003
    Event Type
    Injury
    Date Received
    March 11, 2025
    Report Date
    April 24, 2025
    Manufacturer
    TUTOGEN MEDICAL GMBH
    Product Code
    FTM
    PMA / PMN Number
    K081538
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS NO UNIQUE IDENTIFIERS WERE PROVIDED TUTOGEN MEDICAL GMBH (TMI) WAS UNABLE TO CONDUCT A RECORDS REVIEW. THE AUTHOR WAS CONTACTED AND NO FURTHER DETAILS WILL BE PROVIDED, HOWEVER, IT WAS CONFIRMED THAT NO ADVERSE EFFECTS WERE FILED FOR THE STUDY. CAUSALITY ASSESSMENT FOR THE INDIVIDUAL COMPLICATIONS FOR TUTOMESH WAS REPORTED AS NOT RELATED (NO ADVERSE EFFECTS) BY THE AUTHOR AND FOR OVERALL CONCLUSION, THE USE OF TUTOMESH WAS DESCRIBED AS A SAFE METHOD IN THE ARTICLE. THE MENTIONED COMPLICATIONS REFLECT TYPICAL ADVERSE OCCURRENCES AFTER BREAST RECONSTRUCTION AND MAY ALSO BE CAUSED BY THE SURGICAL PROCEDURE. THEREFORE, TUTOGEN CONCURS WITH THE REPORTER AND CONSIDERS THESE EVENTS AS NOT RELATED.

    Additional Manufacturer Narrative · 0

    NO PRODUCT IDENTIFIERS WERE PROVIDED. TUTOGEN MEDICAL GMBH WILL REQUEST ADDITIONAL INFORMATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THIS INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    TUTOGEN MEDICAL GMBH (TMI), A WHOLLY SUBSIDIARY OF RTI SURGICAL INC INITIATED A COMPLAINT AS A RESULT OF A LITERATURE RESEARCH: IMMEDIATE PREFECTORAL BREAST RECONSTRUCTION USING BOVINE PERICARDIUM MATRIX. BENTZON TT ET. AL., DAN MED J 2025;72(2): A08240522. DOI: 1 0.61409/A08240522. THE PUBLICATION PROVIDES THE RESULTS OF A RETROSPECTIVE STUDY ON IMMEDIATE IMPLANT-BASED BREAST RECONSTRUCTION (IBBR) USING TUTOMESH AND LASER-ASSISTED INDOCYANINE GREEN ANGIOGRAPHY. EIGHTY ONE BREAST RECONSTRUCTIONS IN 56 PATIENTS WERE INCLUDED IN THE STUDY. THE FOLLOWING COMPLICATIONS WERE REPORTED: SKIN NECROSIS (5 EVENTS / 4 PATIENTS), INFECTION (3 EVENTS / 3 PATIENTS), HEMATOMA (2 EVENTS / 2 PATIENTS), WOUND DEHISCENCE (1 EVENT / 1 PATIENT), RIPPLING (11 EVENTS / 8 PATIENTS), BREAST IMPLANT ROTATION (6 EVENTS / 5 PATIENTS), AND BREAST IMPLANT LOSS (3 EVENTS / 3 PATIENTS). THE TOTAL COMPLICATION RATE WAS REPORTED AS 31 (38.2%) EVENTS AND 26 (46.6%) PATIENTS. PATIENT INDIVIDUAL DATA HAVE NOT BEEN PROVIDED TO TMI. ADDITIONALLY, A CAUSALITY ASSESSMENT REGARDING TUTOMESH WAS NOT PROVIDED. THE AUTHORS CONCLUDED THAT PREFECTORAL IBBR UTILIZING TUTOMESH IS A SAFE METHOD, WHICH YIELDS A GOOD AESTHETIC OUTCOME WITHOUT INCREASING THE RISK OF POST OPERATIVE COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1308834 TUTOMESH BOVINE PERICARDIUM FTM TUTOGEN MEDICAL GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other