BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESTEEM 1 PC - 1 PC DRAINABLE INVISICLOSE DRAINABLE POUCH - APS

    MDR report key: 4132822 · Received September 29, 2014

    Report

    Report Number
    9618003-2014-11332
    Event Type
    Injury
    Date Received
    September 29, 2014
    Report Date
    January 28, 2013
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC, INC.
    Product Code
    EZQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE NO NONCONFORMANCES RAISED FOR THIS PRODUCT DURING THE PREVIOUS 12 MONTHS. THERE IS NO INDICATION OF AN ADVERSE TREND OVER THE PAST TWELVE MONTHS (JAN. 2012 TO JAN. 2013) FOR THIS COMPLAINT/PRODUCT.

    Description of Event or Problem · 1

    PER THE END USER, THE TAIL OF THE BAG WAS WELDED AND COULD NOT DRAIN. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607177 ESTEEM 1 PC - 1 PC DRAINABLE INVISICLOSE DRAINABLE POUCH - APS POUCH, COLOSTOMY EZQ CONVATEC DOMINICAN REPUBLIC, INC. 416718 2B01294

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other