BEUDAMED
    FDA Adverse Event Death Summary report: N

    FOLYSIL SILICONE CATHETER

    MDR report key: 21458068 · Received February 25, 2025

    Report

    Report Number
    9610711-2025-00037
    Event Type
    Death
    Date Received
    February 25, 2025
    Date of Event
    June 1, 2024
    Report Date
    December 15, 2025
    Manufacturer
    COLOPLAST A/S
    Product Code
    EZL
    UDI-DI
    03600040127360
    PMA / PMN Number
    K233411
    Removal / Correction Number
    Z-0844-2025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS NOT YET COMPLETE, A FOLLOW UP REPORT WILL BE SUBMITTED ON COMPLETION OF THE INVESTIGATION. B2: DATE IS UNKNOWN. THE PATIENT DIED IN (B)(6) 2024. B3: ESTIMATED DATE.

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE INFORMATION KNOWN, THE QUALITY DATABASE WAS CHECKED AND REVEALED THE FIELD SAFETY NOTICE ASSOCIATED WITH THE CORRECTIVE AND PREVENTIVE ACTION Z-0844-2025. ALL THE AFFECTED PRODUCTS WERE RECALLED ON THE 5 PREVIOUS YEARS. THE INVESTIGATION RESULTED IN SOME CORRECTIVE ACTIONS LIKE THE CHANGE OF THE PACKAGING FOIL, NEW CONTROL TOOLS, AND RETRAINING OF OPERATORS. A SIMILAR CASE STUDY WAS PERFORMED BASED ON THE RECALL SCOPE. DEFECT: PACKAGING ISSUE OR INFECTION FROM (B)(6) 2025: 17 SIMILAR CASES WERE FOUND. A MEDICAL ASSESSMENT WAS ALSO PERFORMED WHICH CONCLUDED: THE RISK OF INFECTION CANNOT BE ELIMINATED, ESSENTIALLY THROUGH A CONTAMINATION CASCADE FROM THE OUTER POUCH BREACH TO THE EXTERNAL SURFACE OF THE INNER POUCH, THEN TO THE SURGEON¿S GLOVE, THEN TO THE PATIENT. TAKING INTO ACCOUNT THE MULTIPLE RISK RATIOS FOR EACH STEP OF THE CASCADE, AND BASED ON THE SENSITIVITY ANALYSIS PERFORMED, THE FINAL RISK IS NOT EXPECTED TO EXCEED THE USUAL HIGHEST RATES REPORTED IN LITERATURE FOR EACH DEVICE FAMILY.

    Additional Manufacturer Narrative · 0

    A SIMILAR CASE STUDY WAS PERFORMED BASED ON THE SCOPE OF THE RECALL. THIS INCLUDED COMPLAINTS REPORTING THE SAME IDENTIFIED PACKAGING ISSUE OR A REPORT OF INFECTION FOR IMPACTED DEVICES: 18 SIMILAR CASES WERE FOUND.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT PASSED AWAY IN (B)(6) 2024 DUE TO SEPSIS. THE PATIENT'S FAMILY CONCLUDED THAT THE USE OF THE FOLYSIL CATHETER HAD A DIRECT CORRELATION WITH THE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393981 FOLYSIL SILICONE CATHETER INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL EZL COLOPLAST A/S 03600040127360

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Death