BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOLYSIL TIEMANN CATH 5/15ML

    MDR report key: 8001688 · Received October 24, 2018

    Report

    Report Number
    9610711-2018-00016
    Event Type
    Injury
    Date Received
    October 24, 2018
    Report Date
    November 19, 2018
    Manufacturer
    COLOPLAST A/S
    Product Code
    EZL
    PMA / PMN Number
    K013172
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED AT COLOPLAST; HOWEVER THE EVALUATION IS NOT YET COMPLETE. WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. ONCE OUR EVALUATION IS COMPLETE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    CHECKING THE QUALITY DATABASES REVEALED NO ANOMALY IN CONNECTION WITH THE DESCRIBED DEFECT. ON OCTOBER 08 WE RECEIVED SAMPLE - WE SEE WEAK BURRS AND ACCEPTABLE ACCORDING TO OUR SPECIFICATION. IT IS UNKNOWN IF THIS COMPLAINT OCCURRED WITH MODEL AA63181002 LOT 6230711, OR WITH MODEL AA63161002 LOT 6369785. BOTH LOTS WERE REVIEWED FOR THIS COMPLAINT, WE SEARCHED FOR OTHER COMPLAINT AND WE DIDN'T FIND OTHER COMPLAINT ON THESE LOTS. THE INCIDENT OF UNEXPECTED SIGNIFICATIVE BLEEDING WAS PROBABLY DUE TO PATIENTS' CONDITION, TREATED BY ANTICOAGULANT IN A CONTEXT OF LONG-TERM URINARY CATHETERIZATION FOR URINARY DISORDER. BASED ON THE ABOVE, THIS COMPLAINT IS NOT CONFIRMED AS A PRODUCT DEFECT.

    Description of Event or Problem · 1

    ACCORDING TO THE AVAILABLE INFORMATION, A MALE PATIENT HAD BLEEDING AFTER THE NEW CATHETER HAD BEEN INSERTED. THE PATIENT USUALLY HAS A PERMANENT CATHETER, IT WAS A ROUTINE CHANGE. THE "PATIENTS" GOT A CATHETER THAT WAS FLUSHED FOR 24 HOURS. THEN THE BLEEDING HAD STOPPED AND THE PATIENTS' OUTCOME WAS AND IS GOOD AFTER THE 24-HOURS-FLUSHING. ADDITIONAL INFORMATION INDICATED THE PATIENT WAS UNDER ANTICOAGULANT THERAPY, OVER 60 YEARS OLD AND HAD A LYING CATHETER WHEN THEY CAME TO THE WARD. THE PATIENT HAD ALSO PREVIOUSLY EXPERIENCED THE SAME KIND OF BLEEDING WITH A NON-COLOPLAST CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838894 FOLYSIL TIEMANN CATH 5/15ML SILICONE CATHETER EZL COLOPLAST A/S

    Patients

    Seq Age Sex Outcome Treatment
    1 Other