BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLYSIL SILICONE CATHETER

    MDR report key: 20078302 · Received August 27, 2024

    Report

    Report Number
    9610711-2024-00212
    Event Type
    Malfunction
    Date Received
    August 27, 2024
    Date of Event
    July 1, 2024
    Report Date
    February 20, 2025
    Manufacturer
    COLOPLAST A/S
    Product Code
    EZL
    UDI-DI
    03600040127605
    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

    WE RECEIVED 9 SEALED SAMPLES WITH SAME ITEM NUMBER, 6 SAMPLES WITH SAME LOT NUMBER AND 3 SAMPLES WITH DIFFERENT LOTS NUMBERS: 8559579, 9472353 & 9362312. AFTER RECEIVING THIS COMPLAINT, WE SEARCHED FOR OTHER COMPLAINTS AND WE DIDN'T FIND OTHER COMPLAINTS ON THESE LOT NUMBERS. THESE 9 PRODUCTS WERE INFLATED WITH 15ML OF WATER AND NO BURSTING OR BALLOON DEFECTS WERE OBSERVED. BALLOONS WERE STILL INFLATED 1 WEEK AND NO ISSUE WAS OBSERVED. DEFECT CANNOT BE REPRODUCED WITH THE SEALED SAMPLES RECEIVED. BURSTING ISSUE WAS KNOWN AND COULD COME FROM VARIOUS CAUSES 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 PRODUCT: FOLYSIL DHF, DEFECT, BURST FROM SEPTEMBER 2020 TO SEPTEMBER 2024, 178 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

    B3: ESTIMATED DATE.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION, THE BALLON BURST. THIS OCCURRED ON A DOZEN DEVICES.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION, THE BALLON BURST. THIS OCCURRED ON A DOZEN DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1465179 FOLYSIL SILICONE CATHETER INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL EZL COLOPLAST A/S 9472348_AA61181002 03600040127605

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown