BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLYSIL OVERGUIDE 5/15 ML CH18

    MDR report key: 3800801 · Received May 8, 2014

    Report

    Report Number
    9610711-2014-00010
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Report Date
    April 9, 2014
    Manufacturer
    COLOPLAST A/S
    Product Code
    EZL
    PMA / PMN Number
    K013174
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS NOT BEEN RETURNED. WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    PATIENT IDENTIFIER: (B)(6). DATE OF EVENT: BEST ESTIMATE: (B)(6) 2014. ACCORDING TO THE INFORMATION RECEIVED, NONE OF THE CATHETERS INVOLVED WITH THIS COMPLAINT DEFLATED DURING USE INSIDE THE PATIENT. AS THE NURSES AND SURGEONS HAVE EXPERIENCED BALLOON DEFLATING IN THE PAST, THEY HAVE TESTED THE BALLOONS BEFORE THE CATHETER IS INSERTED. SOME OF THE TESTED BALLOONS DEFLATED IMMEDIATELY AND OTHERS AFTER ABOUT 24 HOURS. AS SOON AS SOME SALINE SOLUTION WAS LEAKING FROM THE VALVE, THE CATHETERS WERE NOT USED AND WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278495 FOLYSIL OVERGUIDE 5/15 ML CH18 SILICONE FOLEY CATHETER EZL COLOPLAST A/S AA64181002 3930834

    Patients

    Seq Age Sex Outcome Treatment
    1