BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESTEEM 1 PC DRAINABLE INVISICLOSE DRAINABLE

    MDR report key: 3760942 · Received April 14, 2014

    Report

    Report Number
    9618003-2014-00039
    Event Type
    Injury
    Date Received
    April 14, 2014
    Date of Event
    March 17, 2014
    Report Date
    March 19, 2014
    Manufacturer
    CONVATEC INC
    Product Code
    EZQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A SERIOUS INJURY. IT WAS REPORTED TREATMENT FOR THE ALLERGIC REACTION WAS GIVEN TO THE PT, THE DEVICE WAS REMOVED AND A COMPETITOR PRODUCT WAS USED. ADDITIONAL PT INFORMATION WAS RECEIVED, VIA EMAIL, ON (B)(4) 2014 WHICH STATED, "THE LOCOID LOTION WAS PRESCRIBED BY THE OSTOMY NURSE FOLLOWING THE ALLERGIC REACTION." NO ADDITIONAL PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. A RETURN SAMPLE FOR EVALUATION IS NOT EXPECTED. REPORTED TO THE FDA ON (B)(4) 2014.

    Description of Event or Problem · 1

    IT WAS REPORTED AN ALLERGIC REACTION OCCURRED AROUND THE OSTOMY OF A PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226302 ESTEEM 1 PC DRAINABLE INVISICLOSE DRAINABLE POUCH, COLOSTOMY EZQ CONVATEC INC 420343 3K03263

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention