BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILIC FOLEY CATH 5/10 ML/5

    MDR report key: 2241789 · Received September 9, 2011

    Report

    Report Number
    9610711-2011-00005
    Event Type
    Injury
    Date Received
    September 9, 2011
    Report Date
    August 12, 2011
    Manufacturer
    COLOPLAST A/S
    Product Code
    EZL
    PMA / PMN Number
    K013174
    Adverse Event
    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

    (B)(4). ACCORDING TO THE INFORMATION RECEIVED, THE FOLEY CATHETER WAS REPORTED TO HAVE BLOCKED FLOW RATE. THE CATHETER HAD TO BE IRRIGATED FOR SEVERAL TIMES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention