BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESTEEM PLUS ONE-PIECE DRAINABLE POUCH

    MDR report key: 8503218 · Received April 11, 2019

    Report

    Report Number
    8503218
    Event Type
    Malfunction
    Date Received
    April 11, 2019
    Date of Event
    February 2, 2019
    Report Date
    March 29, 2019
    Manufacturer
    CONVATEC, PURCHASING DEPARTMENT
    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 FOUND TO HAVE ADHESIVE THAT DOES NOT STICK. THE PART OF THE DEVICE THAT IS SUPPOSED TO BE STICKY IS NOT STICKY OR TACKY AT ALL. IT IS IMMEDIATELY APPARENT THAT SOMETHING IS WRONG WITH THE PRODUCT. WE HAVE NOTIFIED THE MANUFACTURER AND ARE RETURNING MULTIPLE BOXES. MULTIPLE LOTS ARE AFFECTED. LOT 8B00773, 8K01707, 8G01414, 8J01719, 8K04961, 8G01414.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295582 ESTEEM PLUS ONE-PIECE DRAINABLE POUCH POUCH, COLOSTOMY EZQ CONVATEC, PURCHASING DEPARTMENT 8B00773

    Patients

    Seq Age Sex Outcome Treatment
    1 19710 DA