BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLYSIL SILICONE CATHETER

    MDR report key: 20822236 · Received December 2, 2024

    Report

    Report Number
    9610711-2024-00335
    Event Type
    Malfunction
    Date Received
    December 2, 2024
    Date of Event
    November 1, 2024
    Report Date
    April 11, 2025
    Manufacturer
    COLOPLAST A/S
    Product Code
    EZL
    PMA / PMN Number
    K233411
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER RECEIVING THIS COMPLAINT, WE SEARCHED FOR OTHER COMPLAINTS AND WE DIDN'T FIND OTHER COMPLAINT ON THE LOT NUMBER 9772557. ON JANUARY 29TH, 2025, WE DIDN'T RECEIVE THE SAMPLE. UPON RECEIVE IT, THIS COMPLAINT WILL BE REOPEN AND UPDATE. BURSTING ISSUE 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 PERFOMED BASED ON FOLYSIL SILICONE CATHETER, SAME DEFECT "BALLOON BURST" FROM NOVEMBER 2020 TO NOVEMBER 2024: 188 SIMILAR CASES WERE FOUND (SEE DOCUMENT IN ATTACHMENT). A RMF EVALUATION WAS PERFORMED BASED ON CRIQ247, RISK IDENTIFIED 11500, 11506 & 12500 (HAZARDOUS SITUATION CATHETER BALLOON CANNOT STAY INFLATED OR BURST).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 COMPLAINTS AND WE DIDN'T FIND OTHER COMPLAINTS ON THE LOT NUMBER 9772557. B3: ESTIMATED DATE.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION, THREE CATHETERS HAVE BEEN USED AND ALL THREE BALLOONS BURST.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION, THREE CATHETERS HAVE BEEN USED AND ALL THREE BALLOONS BURST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94048 FOLYSIL SILICONE CATHETER INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL EZL COLOPLAST A/S 9772557_HA61144002

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown