BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PED FOLYSIL CATH 1.5 ML CH06/5

    MDR report key: 3864422 · Received June 10, 2014

    Report

    Report Number
    9610711-2014-00019
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 5, 2014
    Report Date
    May 12, 2014
    Manufacturer
    COLOPLAST A/S
    Product Code
    EZL
    PMA / PMN Number
    K013174
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    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)(6). DATE OF EVENT: (B)(6) 2014. ACCORDING TO THE INFORMATION RECEIVED, A CATHETER WAS INSERTED NORMALLY. AFTER A FEW DAYS THE CATHETER BROKE OFF WHILE THE PATIENT WAS BEING HELD BY HIS MOTHER. THE CATHETER WAS TORN AT THE AREA WHERE IT SEPARATES INTO 2 TUBES/LUMENS. THE PART THAT WAS STILL INSIDE THE PATIENT WAS PULLED OUT EASILY AS IT WAS STICKING OUT. IT WAS REPORTED THAT LOCAL ANESTHESIA WAS USED TO PULL OUT THE BROKEN CATHETER AND A NEW CATHETER WAS INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339193 PED FOLYSIL CATH 1.5 ML CH06/5 SILICONE FOLEY CATHETER EZL COLOPLAST A/S AA61061002

    Patients

    Seq Age Sex Outcome Treatment
    1 Other