BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESTEEM

    MDR report key: 8861516 · Received August 5, 2019

    Report

    Report Number
    8861516
    Event Type
    Malfunction
    Date Received
    August 5, 2019
    Date of Event
    February 2, 2019
    Report Date
    July 16, 2019
    Manufacturer
    CONVATEC
    Product Code
    EZQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    MULTIPLE COLOSTOMY BAGS FROM MULTIPLE LOTS FOUND TO HAVE ADHESIVE THAT DOES NOT STICK. THE LACK OF ADHESIVE CANNOT BE DETECTED UNTIL THE DEVICE IS OPENED. MULTIPLE DEVICES WITHIN EACH LOT ARE AFFECTED. THE NUMBERS OF EACH LOT ARE LISTED HERE. THE DEVICES CANNOT BE USED AND A NEW ONE MUST BE OPENED UNTIL ONE THAT HAS WORKING ADHESIVE IS FOUND. THE BAGS THAT HAVE NON-WORKING NON-STICKING ADHESIVE HAVE BEEN DISCARDED. IT IS AS IF THE BAGS WERE MANUFACTURED WITHOUT ANY OF THE STICKY ADHESIVE HAVING BEEN APPLIED TO THEM. THERE IS NOT A WAY FOR THE CUSTOMER TO KNOW THIS UNTIL THE PACKAGING IS OPENED AND THE CUSTOMER TRIES TO APPLY THE DEVICE--IT SLIPS OFF AND DOES NOT STICK AT ALL. THERE IS ABSOLUTELY NO ADHESION OR STICKINESS. AFFECTED LOTS ARE 8B00773, 8K01707, 8G01414, 8J01719, 8K04961, 8G01414.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655554 ESTEEM POUCH, COLOSTOMY EZQ CONVATEC 416718 8B00773

    Patients

    Seq Age Sex Outcome Treatment
    1