BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLYSIL SILICONE CATHETER

    MDR report key: 20978725 · Received December 19, 2024

    Report

    Report Number
    9610711-2024-00350
    Event Type
    Malfunction
    Date Received
    December 19, 2024
    Date of Event
    November 18, 2024
    Report Date
    April 11, 2025
    Manufacturer
    COLOPLAST A/S
    Product Code
    EZL
    PMA / PMN Number
    K233411
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON 28TH NOVEMBER 2024, WE ARE RECEIVING A USED SAMPLE. THE SAMPLE WAS COMPLETELY SOILED AND ACCORDING TO OUR PROCEDURE SBA06098 "PROCEDURE DE RECEPTION ET DE DECONTAMINATION DES PRODUITS" WAS THROWN AWAY WITHOUT INVESTIGATION. WE WERE UNABLE TO INVESTIGATE FURTHER COMPLAINTS AND CONDUCT DOCUMENTARY INVESTIGATIONS TO LOOK FOR ANY ANOMALY RECORDED DURING PRODUCTION AS NO LOT NUMBER. 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 FAMILY PRODUCT, DEFECT: BURST FROM SEPTEMBER 2020 TO SEPTEMBER 2024: 178 SIMILAR CASES WERE FOUND. A RMF EVALUATION WAS PERFORMED BASED ON CRIQ 247 - RISK IDENTIFIED: 11506 (HAZARDOUS SITUATION: CATHETER BALLOON CANNOT STAY INFLATED OR BURST). THE EVALUATION HAS SHOWN THAT RISKS ARE ADEQUATELY CONTROLLED AND REDUCED AS FAR AS POSSIBLE IN THE STATE OF ART LEVEL. 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.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. WITHOUT THE BENEFIT OF ANALYZING THE DEVICE, COLOPLAST CANNOT COMMENT ON THE CONDITION OF THE DEVICE. SHOULD ADDITIONAL INFORMATION PROMPT US TO ALTER OR SUPPLEMENT ANY INFORMATION OR CONCLUSIONS CONTAINED IN THIS REPORT, A FOLLOW-UP REPORT WILL BE SUBMITTED. B3: ESTIMATED DATE.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION, THE BALLOON WAS DAMAGED AND CAME OFF WHILE IN USE.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION, THE BALLOON WAS DAMAGED AND CAME OFF WHILE IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2099241 FOLYSIL SILICONE CATHETER INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL EZL COLOPLAST A/S

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown