BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLYSIL SILICONE CATHETER

    MDR report key: 20260149 · Received September 19, 2024

    Report

    Report Number
    9610711-2024-00250
    Event Type
    Malfunction
    Date Received
    September 19, 2024
    Date of Event
    August 1, 2024
    Report Date
    December 20, 2024
    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 NONE REGARDING THE LOT NUMBER 9591024. B3: ESTIMATED DATE.

    Additional Manufacturer Narrative · 0

    AFTER RECEIVING THIS COMPLAINT, WE SEARCHED FOR OTHER COMPLAINTS AND WE FOUND NONE REGARDING THE LOT NUMBER 9591024. THE PRODUCT REFERENCE WAS MANUFACTURED WITH AN INTERMEDIATE PRODUCT MANUFACTURED BY OUR SUBCONTRACTOR WHICH WAS INFORMED ABOUT THIS COMPLAINT. ACCORDING TO THE AVAILABLE INFORMATION WE CANNOT CONCLUDE ON A SPECIFIC ROOT CAUSE IN THIS CASE FOR THE BURST. CHECKING THE QUALITY DATABASES REVEALED THIS TYPE OF DEFECT IS KNOWN AND CLOSELY MONITORED. 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 AND THE SAME DEFECT ¿BURST¿ FROM SEPTEMBER 2020 TO SEPTEMBER 2024: 178 SIMILAR CASES WERE FOUND. A RISK MANAGEMENT FILE EVALUATION WAS PERFORMED. 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. B3: ESTIMATED DATE.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION, ONE HOUR AFTER INSERTION, THE BALLOON EXPLODED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1487444 FOLYSIL SILICONE CATHETER INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL EZL COLOPLAST A/S 9591024_HA61181002

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown