BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XCM BIOLOGIC TISSUE MATRIX

    MDR report key: 19763350 · Received July 17, 2024

    Report

    Report Number
    2530154-2024-00001
    Event Type
    Injury
    Date Received
    July 17, 2024
    Date of Event
    January 11, 2024
    Report Date
    July 1, 2024
    Manufacturer
    DSM BIOMEDICAL
    Product Code
    FTM
    UDI-DI
    00081233702230
    PMA / PMN Number
    K091499
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE REMAINS IMPLANTED. 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 FEVER CANNOT BE DETERMINED. NEVERTHELESS, FEVER IS ADDRESSED AS A POTENTIAL HARM IN THE RISK ANALYSIS, WHICH COULD BE RELATED TO MULTIPLE POTENTIAL HAZARDOUS SITUATIONS. REPORTS OF FEVER FROM CLINICAL USE ARE WELL BELOW THE ESTIMATED PROBABILITY OF OCCURENCE IN THE RISK ANALYSIS. NO ADVERSE TRENDS HAVE BEEN DETECTED.

    Description of Event or Problem · 0

    PATIENT IMPLANTED WITH XCM BIOLOGICAL MESH. AFTER SURGERY, PATIENT HAD PROLONGED PYREXIA OF UNKNOWN ORIGIN - PRESUMED REACTION TO THE BIOLOGICAL MESH. THE PATIENT THEN HAD MULTIPLE COURSES OF ANTIBIOTICS AND PROLONGED HOSPITAL ADMISSION DUE TO THIS REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2172119 XCM BIOLOGIC TISSUE MATRIX SUGRICAL MESH FTM DSM BIOMEDICAL 30012-30 KN7010817 00081233702230

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Hospitalization