BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURE PRODUCTS

    MDR report key: 18408979 · Received December 28, 2023

    Report

    Report Number
    1049092-2023-00326
    Event Type
    Malfunction
    Date Received
    December 28, 2023
    Report Date
    December 18, 2023
    Manufacturer
    CONVATEC INC
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE 1 OF 10. D2A: COMMON DEVICE NAME: ULTRA MALE 16. D2B: PROCODE: KOD. 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: 3005471919.

    Description of Event or Problem · 0

    IT WAS REPORTED "10 OF THE CATHETERS WERE COMPLETELY DRIED OUT AND COULD NOT BE USED. PATIENT HAS USED THIS PRODUCT BEFORE. NO ADDITIONAL INFORMATION PROVIDED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1360059 CURE PRODUCTS CATHETER, UROLOGICAL KOD CONVATEC INC ULTRAM16C

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown