BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILIC FOLEY CATH 5/15 ML/5

    MDR report key: 2040216 · Received April 5, 2011

    Report

    Report Number
    9610711-2011-00003
    Event Type
    Injury
    Date Received
    April 5, 2011
    Date of Event
    February 2, 2011
    Report Date
    March 7, 2011
    Manufacturer
    COLOPLAST A/S
    Product Code
    EZL
    PMA / PMN Number
    K013174
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR EVALUATION. 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). DATE OF EVENT: (B)(4) 2011. ACCORDING TO THE INFORMATION RECEIVED, THE FOLEY CATHETER WAS INSERTED (B)(6), 2010 FOLLOWING PROSTATE SURGERY. THE CATHETER WAS INFLATED USING STERILE WATER. ON (B)(6), 2011 THE CATHETER DROPPED OUT OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILIC FOLEY CATH 5/15 ML/5 SILICONE FOLEY CATHETER EZL COLOPLAST A/S AA61181002 7122118

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention