BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESTEEM 1 PC DRAINABLE INVISICCLOSE DRAIN - APS

    MDR report key: 3850461 · Received May 20, 2014

    Report

    Report Number
    9618003-2014-00046
    Event Type
    Injury
    Date Received
    May 20, 2014
    Date of Event
    April 25, 2014
    Report Date
    April 25, 2014
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC, INC.
    Product Code
    EZQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO THIS EVENT IS DEEMED A SERIOUS INJURY. THE END USER STATED SHE CLEANSES HER SKIN WITH WATER, PATS IT DRY, APPLIES 3M NO STING BARRIER SPRAYS ALLOWS TO AIR DRY AND THEN APPLIES THE POUCH. THE END USER ALSO STATED HER MEDICAL DOCTOR ORDERED PRESCRIPTION NYSTATIN POWDER. NO ADDITIONAL PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFO BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. A RETURN SAMPLE FOR EVALUATION IS NOT EXPECTED. REPORTED TO FDA ON (B)(4) 2014.

    Description of Event or Problem · 1

    END USER STATES SHE DEVELOPED RED SPLOTCHY NON OPEN SKIN ON (B)(6) 2014. THE END USER ALSO STATED THE ITCHINESS STARTED IMMEDIATELY POST OPERATION AND REDNESS STARTED WITH RASH ON THE LEFT SIDE OF HER STOMA WHICH EXTENDS APPROXIMATELY ONE (1) INCH ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299195 ESTEEM 1 PC DRAINABLE INVISICCLOSE DRAIN - APS POUCH, COLOSTOMY, 78EZQ EZQ CONVATEC DOMINICAN REPUBLIC, INC. 416718 3K01504

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention