BEUDAMED
    FDA Adverse Event Death Summary report: N

    FOLYSIL SILICONE CATHETER

    MDR report key: 21336900 · Received February 7, 2025

    Report

    Report Number
    9610711-2025-00027
    Event Type
    Death
    Date Received
    February 7, 2025
    Date of Event
    October 1, 2023
    Report Date
    October 30, 2025
    Manufacturer
    COLOPLAST A/S
    Product Code
    EZL
    Removal / Correction Number
    Z-0844-2025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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 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 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.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM IN (B)(6) 2023 AND WAS SUBSEQUENTLY DISCHARGED TO A HOME HEALTH FACILITY. A FOLEY CATHETER WAS UTILIZED EITHER IN THE EMERGENCY ROOM OR THE HOME HEALTH FACILITY. AFTER RECEIVING THE FOLEY CATHETER, THE PATIENT REPORTEDLY DEVELOPED MRSA INFECTION AND PASSED AWAY FOUR WEEKS LATER. NO KNOWN FACTS ESTABLISH WHICH COMPANY MANUFACTURED THE FOLEY CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    880477 FOLYSIL SILICONE CATHETER INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL EZL COLOPLAST A/S

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Death