BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLYSIL SILICONE CATHETER

    MDR report key: 17444375 · Received August 2, 2023

    Report

    Report Number
    9610711-2023-00162
    Event Type
    Malfunction
    Date Received
    August 2, 2023
    Report Date
    January 9, 2024
    Manufacturer
    COLOPLAST A/S
    Product Code
    EZL
    UDI-DI
    03600040127490
    PMA / PMN Number
    K013174
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. SHOULD ADDITIONAL FACTS PROMPT US TO ALTER OR SUPPLEMENT ANY INFORMATION OR CONCLUSIONS CONTAINED IN THE ORIGINAL MDR OR IN ANY PRIOR SUPPLEMENTAL REPORTS, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    ON THE SAMPLE RECEIVED THE BALLOON WAS BURST WITHOUT MISSING PARTS. ACCORDING TO THE SUBCONTRACTOR'S INVESTIGATION THIS ISSUE WAS PROBABLY DUE TO A RAW MATERIAL DEFECT. NO OTHER COMPLAINT WAS FOUND REGARDING THE LOT NUMBER 8781890. CHECKING THE QUALITY DATABASES REVEALED ONE NON-CONFORMITY IN RELATION TO THE DESCRIBED DEFECT AND A CORRECTIVE AND PREVENTIVE ACTION ARE ONGOING.

    Description of Event or Problem · 0

    ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE HAD A BALLOON BURST. THE DEVICE WAS PLACED IN THE MORNING. IN THE AFTERNOON, THE DEVICE FELL OFF AND THE BALLOON WAS DEFLATED. THE BALLOON BURST WHEN 15 ML WATER WAS INJECTED TO CHECK THE DEVICE. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION, A BALLOON BURST ON A FOLYSIL CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797205 FOLYSIL SILICONE CATHETER INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL EZL COLOPLAST A/S 8781890_AA61161002 03600040127490

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown