BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLLISTER

    MDR report key: 3072401 · Received April 16, 2013

    Report

    Report Number
    3072401
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    June 27, 2012
    Report Date
    April 16, 2013
    Manufacturer
    HOLLISTER
    Product Code
    FAQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US

    Narratives

    Description of Event or Problem · 1

    PATIENT WENT HOME WITH THE CATHETER BAG; APPROXIMATELY FIVE DAYS LATER, IT STARTED TO LEAK IN THE LOWER LEFT EXPANSION JOINT AREA. THE HOSPITAL REPLACED IT. LESS THAN 24 HOURS LATER THE SECOND BAG STARTED LEAKING IN THE SAME PLACE AS THE FIRST ONE. CATHETER WAS THEN REMOVED.MANUFACTURER RESPONSE FOR LARGE LEG CATHETER BAG, (BRAND NOT PROVIDED) (PER SITE REPORTER).WE NOTIFIED THE COMPANY OF THE ISSUE SO THAT THEY CAN HAVE IT ON FILE. THE COMPANY KEEPS THESE ON FILE AND IF THEY GET MULTIPLE INSTANCES, THEN THEY LOOK TO RECALL OR MAKE CHANGES TO THE PRODUCT. AS FOR NOW THEY DID NOT HAVE MORE THAN THIS INSTANCE ON FILE SO IF THIS HAPPENS AGAIN WE WILL NEED TO FOLLOW THE SAME PROCESS AND LOOK TO HAVE THE MANUFACTURER WORK WITH US ON CORRECTING THE PRODUCT.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?URINARY CATHETERIZATION.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163025 HOLLISTER BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE FAQ HOLLISTER * 2F158

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR