BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLYSIL SILICONE CATHETER

    MDR report key: 20091288 · Received August 28, 2024

    Report

    Report Number
    9610711-2024-00217
    Event Type
    Malfunction
    Date Received
    August 28, 2024
    Date of Event
    August 1, 2024
    Report Date
    December 31, 2024
    Manufacturer
    COLOPLAST A/S
    Product Code
    EZL
    UDI-DI
    03600040242186
    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: 9261344 WITH THE SAME DEFECT. WE RECEIVED 1 SEALED SAMPLE WITH SAME ITEM NUMBER AND SAME LOT NUMBER. THIS SAMPLE WAS INFLATED WITH 10ML OF WATER AND NO BURSTING OR BALLOONS DEFECT WERE OBSERVED. BALLOONS STILL INFLATED 1 WEEK AND NO ISSUE WAS OBSERVED. DEFECT CANNOT BE REPRODUCED WITH SAMPLE RECEIVED. BURSTING ISSUES WERE 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.

    Additional Manufacturer Narrative · 0

    AFTER RECEIVING THIS COMPLAINT, WE SEARCHED FOR OTHER COMPLAINTS AND WE FOUND NONE REGARDING THE LOT NUMBER 9261344 WITH THE SAME DEFECT. B3: ESTIMATED DATE.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION, THE BALLOON EXPLODED DURING INSERTION.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION, THE BALLOON EXPLODED DURING INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1465395 FOLYSIL SILICONE CATHETER INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL EZL COLOPLAST A/S 9261344_HA61161002 03600040242186

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown