BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNO SIL 2W STD CH6 (10 800) INT

    MDR report key: 6038386 · Received October 18, 2016

    Report

    Report Number
    9611710-2016-00135
    Event Type
    Malfunction
    Date Received
    October 18, 2016
    Report Date
    September 20, 2016
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    KOD
    PMA / PMN Number
    K770256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 05/2016. BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. NO PATIENT HARM WAS REPORTED. NO LOT NUMBER OR PRODUCT EVALUATION SAMPLE IS AVAILABLE. A DETAILED INVESTIGATION OR BATCH REVIEW CANNOT BE CONDUCTED. THEREFORE THIS EVALUATION WILL BE CLOSED AND WILL BE MONITORED THROUGH OUR POST MARKET PRODUCT MONITORING REVIEW PROCESS. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    REPORTER STATED "THE BUBBLING PROTRUSIONS, WHICH WERE MARKED IN BLUE, WERE NOTED OVER THE CATHETER SHAFT AND THE BALLOON FAILED TO INFLATE JUST IN USE." INFORMATION CLARIFIED AT FOLLOW UP: THE CATHETER SURFACE BUBBLED AT ATTEMPTED BALLOON INFLATION AND THE BALLOON DID NOT INFLATE. THE AREA OF THE SHAFT WHICH BUBBLED WAS MARKED IN BLUE ON THE PHOTOS PROVIDED. THE PATIENT WAS DISCHARGED IN STABLE CONDITION. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689744 UNO SIL 2W STD CH6 (10 800) INT CATHETER, UROLOGICAL KOD UNOMEDICAL SDN BHD MM53120605

    Patients

    Seq Age Sex Outcome Treatment
    1