BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PED FOLYSIL CATH 1.5ML CH06/5

    MDR report key: 5402699 · Received February 1, 2016

    Report

    Report Number
    9610711-2015-00032
    Event Type
    Malfunction
    Date Received
    February 1, 2016
    Report Date
    October 7, 2015
    Manufacturer
    COLOPLAST A/S
    Product Code
    EZL
    UDI-DI
    03600040126844
    PMA / PMN Number
    K013174
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    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 ADDITIONAL FACTS PROMPT US TO ALTER OR SUPPLEMENT ANY INFORMATION OR CONCLUSIONS CONTAINED IN THE ORIGINAL MDR OR IN ANY PRIOR SUPPLEMENTAL REPORTS, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ACCORDING TO THE INFORMATION RECEIVED, ONCE THE CATHETER WAS INSERTED IN THE BLADDER AND THE BALLOON, THERE WERE NO SIGNS OF RESISTANCE. WHEN THE CATHETER WAS REMOVED, THE TIP AND THE BALLOON ITSELF WERE EVIDENTLY BROKEN. A NEW CATHETER WAS THEN INSERTED. CHEST AND ABDP, EM X-RAYS PERFORMED TO CHECK THE CVC POSITIONING REVEALED NO FOREIGN BODIES IN THE BLADDER. THERE WERE NO CLINICAL CONSEQUENCES. NO ANOMALY NOTICED BEFORE INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61795 PED FOLYSIL CATH 1.5ML CH06/5 SILICON FOLEY CATHETER EZL COLOPLAST A/S AA61061002 4550196 03600040126844

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Unknown Required Intervention