BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLYSIL SILICONE CATHETER

    MDR report key: 17615385 · Received August 24, 2023

    Report

    Report Number
    9610711-2023-00188
    Event Type
    Malfunction
    Date Received
    August 24, 2023
    Report Date
    April 16, 2024
    Manufacturer
    COLOPLAST A/S
    Product Code
    EZL
    UDI-DI
    03600040129975
    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

    AFTER RECEIVING THIS COMPLAINT, WE SEARCHED FOR OTHERS COMPLAINT REGARDING THE LOT NUMBER 8911347, AND WE DIDN'T FIND ANY OTHER COMPLAINT WITH THE SAME DEFECT. CHECKING THE QUALITY DATABASES REVEALED ONE CORRECTIVE AND PREVENTIVE ACTION ARE ONGOING MONITORING CAPA-000152: "BALLOON ISSUES ON FOLYSIL AND SILICONE PROSTATIC CATHETERS¿. THE MONITORING IS DONE FOR DEFLATION ISSUE AND IS BELOW THE THRESHOLD. SUBCONTRACTOR INVESTIGATION REVEALED THAT A WATER INFLATION TEST WAS CARRIED OUT ON THE SAMPLE RECEIVED AND NO DIFFICULTY IN DEFLATION, THE WATER WAS REMOVED EASILY.

    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.

    Description of Event or Problem · 0

    ACCORDING TO AVAILABLE INFORMATION, WATER COULD NOT BE REMOVED FROM THE BALLOON OF THIS DEVICE. DURING THE INFLATION TEST, THE WATER COULD NOT BE REMOVED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    ACCORDING TO AVAILABLE INFORMATION, WATER COULD NOT BE REMOVED FROM THE BALLOON OF THIS DEVICE. DURING THE INFLATION TEST, THE WATER COULD NOT BE REMOVED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1038273 FOLYSIL SILICONE CATHETER INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL EZL COLOPLAST A/S 8911347_AA64161002 03600040129975

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown