BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENTLECATH OTHER

    MDR report key: 18548795 · Received January 20, 2024

    Report

    Report Number
    3005778470-2024-00236
    Event Type
    Malfunction
    Date Received
    January 20, 2024
    Report Date
    January 12, 2024
    Manufacturer
    UNOMEDICAL S.R.O.
    Product Code
    KOD
    UDI-DI
    00768455145539
    PMA / PMN Number
    K172924
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MDR 3005778470-2024-00236 / 5 OF 40. (B)(6). BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. THIS COMPLAINT HAS BEEN EVALUATED. NO LOT NUMBER IS AVAILABLE. A DETAILED INVESTIGATION OR BATCH REVIEW CANNOT BE CONDUCTED. THEREFORE, THIS EVALUATION WILL BE CLOSED. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER REPORTING SITE: 1049092 MANUFACTURING SITE: 3005778470.

    Description of Event or Problem · 0

    END USER REPORTS THE INDICATOR LINE ON THE FUNNEL OF THE CATHETER IS NOT ALWAYS ALIGNED WITH THE COUDÉ TIP. NO HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2407230 GENTLECATH OTHER CATHETER, UROLOGICAL KOD UNOMEDICAL S.R.O. 501014 00768455145539

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown