BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESTEEM 1 PC - 1 PC DRAINABLE INVISICLOSE DRAIN

    MDR report key: 4132829 · Received September 29, 2014

    Report

    Report Number
    9618003-2014-11752
    Event Type
    Injury
    Date Received
    September 29, 2014
    Report Date
    June 17, 2013
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC, INC.
    Product Code
    EZQ
    PMA / PMN Number
    K833625
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT HAS BEEN EVALUATED BY THE SITE OF MANUFACTURE. MEDICAL AND REGULATORY STATEMENTS HAVE BEEN REVIEWED. A LOT NUMBER COULD NOT BE OBTAINED THEREFORE A REVIEW OF THE BATCH RECORD DATA COULD NOT BE PERFORMED WITHOUT A VALID LOT NUMBER. THERE IS NO INDICATION OF AN ADVERSE TREND OVER THE PAST TWELVE MONTHS ((B)(4) 2013) FOR THIS COMPLAIN/PRODUCT.

    Description of Event or Problem · 1

    PATIENT REPORTED THAT SHE USED TWO BOXES OF WAFERS AND NOTICED THAT THE LEFT SIDE OF THE MASS BECAME HARD AND DRIED OUT, AFTER TWO DAYS OF USE. AS A RESULT THE CRACKS CREATED A SHARP EDGE AND SMALL PIECES OF THE WAFER BECAME DISLODGED. SHE FIRST NOTICED WHAT WAS HAPPENING WHEN SHE FELT HER SKIN WAS SCRATCHED. SHE STATED THE SCRATCHING WAS NOT ENOUGH TO BREAK THE SKIN BUT WAS UNCOMFORTABLE. THE END USER SUBSEQUENT OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606466 ESTEEM 1 PC - 1 PC DRAINABLE INVISICLOSE DRAIN POUCH COLOSTOMY EZQ CONVATEC DOMINICAN REPUBLIC, INC. 416732

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other