BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XCM BIOLOGIC TISSUE MATRIX

    MDR report key: 19763737 · Received July 17, 2024

    Report

    Report Number
    2530154-2024-00002
    Event Type
    Injury
    Date Received
    July 17, 2024
    Date of Event
    May 20, 2024
    Report Date
    August 14, 2024
    Manufacturer
    DSM BIOMEDICAL
    Product Code
    FTM
    UDI-DI
    00081233702232
    PMA / PMN Number
    K094061
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL CLINICAL INFORMATION HAS BEEN REQUESTED. INVESTIGATION IS ONGOING AND LIMITED TO REVIEW PROVIDED BY USER AND DEVICE HISTORY RECORD REVIEW. RESULTS AND CONCLUSIONS WILL BE SUBMITTED IN A FOLLOW UP REPORT.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER'S INVESTIGATION WAS LIMITED TO REVIEW OF THE DEVICE HISTORY RECORD AND LIMITED CLINICAL INFORMATION FROM THE COMPLAINT REPORTER. THE DEVICE HISTORY RECORD INVESTIGATION DETERMINED THAT THE PRODUCT WAS PRODUCED ACCORDING TO SPECIFICATION, INCLUSIVE OF TOTAL STERILIZATION DOSE, AND MET POST-STERILIZATION ENDOTOXIN TESTING REQUIREMENTS. BASED ON THE INVESTIGATION AND THE AVAILABLE INFORMATION FROM THE REPORTER, THE ROOT CAUSE OF THE INFECTION CANNOT BE DETERMINED. NEVERTHELESS, INFECTION IS ADDRESSED AS A POTENTIAL HARM IN THE RISK ANALYSIS, WHICH COULD BE RELATED TO MULTIPLE POTENTIAL HAZARDOUS SITUATIONS. REPORTS OF INFECTION FROM CLINICAL USE ARE BELOW THE ESTIMATED PROBABILITY OF OCCURENCE IN THE RISK ANALYSIS. NO ADVERSE TRENDS HAVE BEEN DETECTED.

    Description of Event or Problem · 0

    ON (B)(6) 2024 THE PATIENT WAS OPERATED ON FOR A CHEST WALL RESECTION OF ANTERIOR 3RD/4TH RIB AND HEMISTERNUM. RECONSTRUCTION WITH XCM MESH AND LD FLAP WAS PERFORMED. PATIENT INITIALLY RECOVERED WELL AND DISCHARGED HOME. WHILE AT HOME, THE PATIENT BECAME UNWELL WITH FEVERS AND GENERALIZED FATIGUE. ON (B)(6) 2024 THE PATIENT PRESENTED TO LOCAL HOSPITAL WITH SIGNS OF INFECTION. THE PATIENT WAS TREATED WITH ANTIBIOTICS. SHE WAS THEN READMITTED TO HOSPITAL ON (B)(6) 2024 DUE TO SIGNS OF INFECTED MESH/OPERATIVE SITE. ON (B)(6) 2024 THE PATIENT UNDERWENT WASHOUT OF CHEST WALL, DRAINAGE OF COLLECTION AND REMOVAL OF MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351734 XCM BIOLOGIC TISSUE MATRIX SURGICAL MESH FTM DSM BIOMEDICAL 30012-32 KN7010032 00081233702232

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R