BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOLYSIL X-TRA SGL CH 14

    MDR report key: 2696134 · Received February 8, 2012

    Report

    Report Number
    9610711-2012-00004
    Event Type
    Injury
    Date Received
    February 8, 2012
    Date of Event
    November 3, 2011
    Report Date
    January 9, 2012
    Manufacturer
    COLOPLAST A/S
    Product Code
    EZL
    PMA / PMN Number
    K013172
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    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

    ACCORDING TO THE INFORMATION RECEIVED, A BALLOON BURST WAS REPORTED FOR A FOLEY CATHETER. THE PATIENT DESCRIBED HE HAD THE URGE TO PASS URINE AND THEN COULD FEEL THE BALLOON BURSTING INSIDE. HE THEN FELT THE SENSATION OF WATER SPILLING. FOLLOWING THIS THE CATHETER FELL OUT WITH THE BALLOON DEFLATED. THE PATIENT HAD TO BE RE-CATHETERIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOLYSIL X-TRA SGL CH 14 SILICONE FOLEY CATHETER EZL COLOPLAST A/S AA8A141002 1102175, 11020865, 11080266

    Patients

    Seq Age Sex Outcome Treatment
    1 Other