BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOLYSIL SILICONE CATHETER

    MDR report key: 21415982 · Received February 19, 2025

    Report

    Report Number
    9610711-2025-00032
    Event Type
    Injury
    Date Received
    February 19, 2025
    Date of Event
    January 27, 2025
    Report Date
    April 25, 2025
    Manufacturer
    COLOPLAST A/S
    Product Code
    EZL
    UDI-DI
    03600040126844
    PMA / PMN Number
    K233411
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER RECEIVING THIS COMPLAINT AND DETERMINED INCRIMINATED LOT NUMBER, WE SEARCHED FOR OTHER COMPLAINT AND WE DIDN'T FIND OTHER COMPLAINTS REGARDING THE LOT NUMBER 8923533. BURST ISSUE OF SILICONE BALLOON IS KNOWN BUT ACCORDING TO THE AVAILABLE INFORMATION WE CANNOT CONCLUDE ON A SPECIFIC ROOT CAUSE IN THIS CASE. QUALITY DATABASE WAS CHECKED AND REVEALED A CORRECTIVE AND PREVENTIVE ACTION: CAPA-000152. "BALLOON ISSUES ON FOLYSIL AND SILICONE PROSTATIC CATHETERS" WAS OPENED AND MONTHLY MONITORING. NO CORRECTIVE ACTION WILL BE IMPLEMENTED AS OUR TREND IS NOT INCREASING AND THE THRESHOLD IS NOT EXCEEDED. A SIMILAR CASE STUDY WAS PERFORMED BASED ON FOLYSIL FAMILY PRODUCT, DEFECT: BURST FROM FEBRUARY 2021 TO FEBRUARY 2025: 184 SIMILAR CASES WERE FOUND. THE EVALUATION HAS SHOWED THAT RISKS ARE ADEQUATELY CONTROLLED AND REDUCED AS FAR AS POSSIBLE IN THE STATE OF ART. BASED ON THIS, WE CAN CONCLUDE THAT RESIDUAL RISKS ARE ADEQUATELY CONTROLLED AND REDUCED AS FAR AS POSSIBLE, AND THE RESIDUAL RISKS ASSOCIATED WITH THE USE OF THE PRODUCT ARE ACCEPTABLE WHEN WEIGHED AGAINST THE BENEFITS TO THE PATIENT/USER. IT IS CONCLUDED THAT THE RISKS IDENTIFIED ARE STILL ACCEPTABLE AND CONSIDERED AS SAFE.

    Additional Manufacturer Narrative · 0

    AFTER RECEIVING THIS COMPLAINT, WE SEARCHED FOR OTHER COMPLAINT AND WE DIDN'T FIND OTHER COMPLAINTS REGARDING THE LOT NUMBER 8923533. THE INVESTIGATION IS NOT YET COMPLETE, A FOLLOW UP REPORT WILL BE SUBMITTED ON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION, 6 FRENCH FOLEY WAS PLACED INTO THE PATIENT, INFLATED AND PULLED BACK ON THE LINE TO MAKE SURE THAT THE BALLOON AND THE FOLEY WAS SECURE AND THE FOLEY CAME OUT BUT THE BALLOON AND THE END OF THE FOLEY WAS NOT INTACT. PIECES OF THE FOLEY REMAIN INSIDE OF THE PATIENT'S BLADDER. UNABLE TO LOCATE MISSING FRAGMENT OF BALLOON.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION, 6 FRENCH FOLEY WAS PLACED INTO THE PATIENT, INFLATED AND PULLED BACK ON THE LINE TO MAKE SURE THAT THE BALLOON AND THE FOLEY WAS SECURE AND THE FOLEY CAME OUT BUT THE BALLOON AND THE END OF THE FOLEY WAS NOT INTACT. PIECES OF THE FOLEY REMAIN INSIDE OF THE PATIENT'S BLADDER. UNABLE TO LOCATE MISSING FRAGMENT OF BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1389839 FOLYSIL SILICONE CATHETER INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL EZL COLOPLAST A/S 8923533_AA61061002 03600040126844

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention