BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLYSIL SILICONE CATHETER

    MDR report key: 20727545 · Received November 19, 2024

    Report

    Report Number
    9610711-2024-00320
    Event Type
    Malfunction
    Date Received
    November 19, 2024
    Date of Event
    October 9, 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 FOUND TWO COMPLAINTS REGARDING THE LOT NUMBER 9700645: (B)(4) FOR DEFLATED BALLOON AND (B)(4) FOR BALLOON BURST. THE AVAILABLE STOCKS WERE CHECKED ON OCTOBER 28TH 2024, WE HAVE NO MORE PIECES OF THIS LOT AVAILABLE. BURST AND DEFLATED ISSUE OF SILICONE BALLOON ARE 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 PRODUCT, DEFECT BALLOON BURST FROM OCTOBER 2020 TO OCTOBER 2024, 210 SIMILAR CASES WERE FOUND. A RMF EVALUATION WAS PERFORMED BASED ON CRIQ 247 - RISK IDENTIFIED 11500 (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 LEVEL. 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.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION, THE URINARY CATHETER BALLOON WAS PUNCTURED AND FELL OUT. NO FRAGMENTS OF THE BALLOON WERE OBSERVED AND A NEW URINARY CATHETER WAS INSERTED. PATIENT EXPERIENCED DISCOMFORT DUE TO REPETITIVE CATHETERIZATIONS.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION, THE URINARY CATHETER BALLOON WAS PUNCTURED AND FELL OUT. NO FRAGMENTS OF THE BALLOON WERE OBSERVED AND A NEW URINARY CATHETER WAS INSERTED. PATIENT EXPERIENCED DISCOMFORT DUE TO REPETITIVE CATHETERIZATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2431402 FOLYSIL SILICONE CATHETER INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL EZL COLOPLAST A/S 9700645_AA61201002

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown