BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2862306 · Received November 29, 2012

    Report

    Report Number
    2862306
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    October 31, 2012
    Report Date
    November 29, 2012
    Manufacturer
    HOLLISTER
    Product Code
    EXB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    DURING EXAMINATION OF THE HOLLISTER OSTOMY BAG 3778, IT WAS NOTICED THAT THE SMALL CLEAR BEADS ON THE INSIDE OF THE BAG BROKE OFF. THE BAG WAS REPLACED. THIS IS NOT THE FIRST TIME THIS HAS HAPPENED. IN PREVIOUS EVENTS ((B)(4) 2011) THE PLASTIC PIECE MIGRATED INTO THE STOMA. DESPITE MANUFACTURER'S CLAIMS TO BE IMPROVING THE PRODUCT, IT IS STILL PROBLEMATIC.======================MANUFACTURER RESPONSE FOR OSTOMY BAG, HOLLISTER 3778 (PER SITE REPORTER)======================THE MANUFACTURE HAS BEEN AWARE FOR SOME TIME OF THE PROBLEM. IT WAS INITIALLY REPORTED FOR (B)(4) 2011 EVENT WAS FILED. WE CONTINUE TO BE IN CONTACT WITH THEM, AND ALERT THEM THAT WE ARE STILL HAVING PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * COLLECTOR, OSTOMY EXB HOLLISTER * *

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO