BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLYSIL SILICONE CATHETER

    MDR report key: 21868134 · Received April 18, 2025

    Report

    Report Number
    9610711-2025-00072
    Event Type
    Malfunction
    Date Received
    April 18, 2025
    Date of Event
    March 25, 2025
    Report Date
    June 30, 2025
    Manufacturer
    COLOPLAST A/S
    Product Code
    EZL
    UDI-DI
    03600040127230
    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 COMPLAINT REGARDING THE LOT NUMBER. THE INVESTIGATION IS NOT YET COMPLETE, A FOLLOW UP REPORT WILL BE SUBMITTED ON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    AFTER RECEIVING THIS COMPLAINT, WE SEARCHED FOR OTHER COMPLAINTS AND WE FOUND NONE REGARDING THE LOT NUMBER 9792211. ON 13TH JUNE 2025 WE DID NOT RECEIVED SAMPLE. WITHOUT SAMPLE WE CANNOT DO MORE THAN DOCUMENTARY INVESTIGATION WHICH REVEALED NO ANOMALY REGISTERED DURING PRODUCTION. HOWEVER, DEFLATION ISSUE OF SILICONE BALLOON IS KNOWN BUT ACCORDING TO THE AVAILABLE INFORMATION WE CANNOT CONCLUDE ON A SPECIFIC ROOT CAUSE IN THIS CASE. ACCORDING TO THE INFORMATION KNOWN 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 DEFLATION DIFFICULT/IMPOSSIBLE BETWEEN MARCH 2021 AND MARCH 2025, 58 SIMILAR CASES WERE FOUND.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION, WHEN REMOVING THE INDWELLING CATHETER, IT WAS IMPOSSIBLE TO DEFLATE THE BALLOON. THE BALLOON WAS NOT CHECKED BEFOREHAND. CATHETERIZATION WITHOUT PROBLEMS, BUT THERE WAS NO URINE IMMEDIATELY, SO THE DECISION WAS MADE TO INFLATE THE BALLOON WITH 10ML OF WATER TO BE ABLE TO MOBILIZE THE CATHETER. THERE WAS NO PROBLEM INFLATING IT. THE CATHETER WAS IMMEDIATELY REMOVED, BUT THE BALLOON COULD NOT BE DEFLATED, AND THE DECISION WAS MADE TO CUT THE CATHETER. WATER DRAINED SMOOTHLY AND THE CATHETER WAS REMOVED WITHOUT FORCING. THE PATIENT EXPERIENCED NO PAIN.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION, WHEN REMOVING THE INDWELLING CATHETER, IT WAS IMPOSSIBLE TO DEFLATE THE BALLOON. THE BALLOON WAS NOT CHECKED BEFOREHAND. CATHETERIZATION WITHOUT PROBLEMS, BUT THERE WAS NO URINE IMMEDIATELY, SO THE DECISION WAS MADE TO INFLATE THE BALLOON WITH 10ML OF WATER TO BE ABLE TO MOBILIZE THE CATHETER. THERE WAS NO PROBLEM INFLATING IT. THE CATHETER WAS IMMEDIATELY REMOVED, BUT THE BALLOON COULD NOT BE DEFLATED, AND THE DECISION WAS MADE TO CUT THE CATHETER. WATER DRAINED SMOOTHLY AND THE CATHETER WAS REMOVED WITHOUT FORCING. THE PATIENT EXPERIENCED NO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32388 FOLYSIL SILICONE CATHETER INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL EZL COLOPLAST A/S 9792211_AA61121002 03600040127230

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown