BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PED FOLYSIL CATH 3 ML CH08/5

    MDR report key: 3071206 · Received April 22, 2013

    Report

    Report Number
    9610711-2013-00003
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    February 20, 2013
    Report Date
    March 4, 2013
    Manufacturer
    COLOPLAST A/S
    Product Code
    EZL
    PMA / PMN Number
    K013174
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USED SAMPLE WAS RECEIVED. AT VISUAL OBSERVATION WE CAN SEE A SLIT ON THE DRAINAGE CHANNEL OF THE FUNNEL (AT THE JUNCTION OF THE DRAINAGE CHANNEL AND THE INFLATION CHANNEL). BASED UPON THE INFORMATION ABOVE, THIS COMPLAINT IS CONFIRMED AS REPORTED.

    Description of Event or Problem · 1

    (B)(6). DATE OF EVENT: (B)(6) 2013. ACCORDING TO THE INFORMATION RECEIVED, DURING THE CHANGE OF A URINARY BAG, A CRACK WAS FOUND ON THE FUNNEL OF THE CATHETER AND THEREFORE THE CATHETER COULD NOT BE REMOVED. THE PATIENT'S DISCHARGE WAS DELAYED. ADDITIONAL INTERVENTION REQUIRING GENERAL ANESTHESIA WAS NECESSARY TO THE CHANGE THE CATHETER. A PERINEAL URTHROSTOMY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172517 PED FOLYSIL CATH 3 ML CH08/5 SILICONE FOLEY CATHETER EZL COLOPLAST A/S AA61081002 12011741

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Required Intervention