BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVELIFE 1 PC DRAINABLE POUCH W/ DURAHESIVE

    MDR report key: 3763251 · Received April 10, 2014

    Report

    Report Number
    9618003-2014-00028
    Event Type
    Injury
    Date Received
    April 10, 2014
    Date of Event
    March 17, 2014
    Report Date
    March 17, 2014
    Manufacturer
    CONVATEC INC.
    Product Code
    EZQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 THE RASH BEGAN WHEN HE WAS USING ANOTHER BRAND OF OSTOMY PRODUCTS AND WAS UNABLE TO RECALL THE NAME. THE END USER ALSO STATED THE RASH HAS NOT GOTTEN BETTER, BUT HAS NOT GOTTEN ANY WORSE SINCE TRYING THE CONVATEC DEVICE. THE END USER STATED HIS STOMA FLUCTUATES. THE END USER WENT ON TO STATED HE WAS PRESCRIBED NYSTATIN POWDER BY A FREE CLINIC, HOWEVER, HE HAS NOT TRIED IT AS OF YET. THE END USER WAS EDUCATED ON PROPER SKIN CARE, APPLICATION OF THE PRESCRIPTION POWDER FOLLOWED BY THE APPLICATION OF THE PROTECTIVE BARRIER. THE END USER STATED HE DID NOT HAVE THE LOT NUMBER OF THE DEVICE AVAILABLE. NO ADD'L PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADD'L INFO BECOME AVAILABLE, A F/U REPORT WILL BE SUBMITTED. A RETURN SAMPLE FOR EVAL IS NOT EXPECTED. REPORTED TO THE FDA ON (B)(4) 2014. NOTE: THE ACTUAL DATE OF EVENT IS UNK, SO THE DATE USED WAS THE DATE CONVATEC BECAME AWARE.

    Description of Event or Problem · 1

    AN END USER NOTED A FUNGAL RASH TO HIS PERISTOMAL SKIN. THE END USER STATED THE RASH IS LOCATED ALMOST 360 DEGREES AROUND HIS STOMA AND EXTENDS TO HIS PUBIC AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216199 ACTIVELIFE 1 PC DRAINABLE POUCH W/ DURAHESIVE POUCH, COLOSTOMY 78 EZQ CONVATEC INC. 400599 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention