BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLEY CATHETER 16 FR.

    MDR report key: 4110871 · Received September 16, 2014

    Report

    Report Number
    9611710-2014-00286
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    July 16, 2014
    Report Date
    August 27, 2014
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    EZL
    PMA / PMN Number
    K841554
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THERE WERE NO REPORTS OF THE PATIENT BEING HARMED AS A RESULT OF THIS MALFUNCTION. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. A RETURN SAMPLE IS NOT EXPECTED AND THE LOT NUMBER WAS NOT PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT WATER COULD NOT BE WITHDRAWN FROM BALLOON WHILE REMOVING THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571723 FOLEY CATHETER 16 FR. CATHETER, RETENTION TYPE, BALLOON, 78EZL EZL UNOMEDICAL SDN BHD UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention