BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    (2BO) CATHETER 2WAY 5CC CH16

    MDR report key: 3440828 · Received October 31, 2013

    Report

    Report Number
    2125050-2013-00398
    Event Type
    Malfunction
    Date Received
    October 31, 2013
    Date of Event
    August 15, 2013
    Report Date
    October 2, 2013
    Manufacturer
    COLOPLAST MANUFACTURING US LLC
    Product Code
    FCM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION. WITHOUT THE BENEFIT OF ANALYZING THE DEVICE, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    DATE OF EVENT: (B)(6) 2013. ACCORDING TO THE INFORMATION RECEIVED, A BALLOON CATHETER WOULD NOT DEFLATE. THE USER WAS SENT TO THE HOSPITAL TO HAVE THE DEVICE REMOVED. NO ADVERSE EFFECT FROM THE FOLEY BALLOON FOR NOT DEFLATING WAS STATED IN THE COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561288 (2BO) CATHETER 2WAY 5CC CH16 URINARY CATHETER FCM COLOPLAST MANUFACTURING US LLC UC25161400

    Patients

    Seq Age Sex Outcome Treatment
    1 Other