BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILIC FOLEY CATH 5/10ML/5

    MDR report key: 3884376 · Received June 19, 2014

    Report

    Report Number
    9610711-2014-00021
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 23, 2014
    Manufacturer
    COLOPLAST A/S
    Product Code
    EZL
    PMA / PMN Number
    K013174
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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

    (B)(6). ACCORDING TO THE INFORMATION RECEIVED, UPON EXAMINING THE CATHETER THROUGH THE PACKAGING, THERE APPEARED TO BE A HAIR ON THE BALLOON OF THE CATHETER. THE CATHETER WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361888 SILIC FOLEY CATH 5/10ML/5 SILICONE FOLEY CATHETER EZL COLOPLAST A/S AA61141002 3823705

    Patients

    Seq Age Sex Outcome Treatment
    1