BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVELIFE® ONE-PIECE POUCH

    MDR report key: 6111783 · Received November 17, 2016

    Report

    Report Number
    9618003-2016-00058
    Event Type
    Injury
    Date Received
    November 17, 2016
    Report Date
    April 17, 2015
    Manufacturer
    CONVATEC INC.
    Product Code
    EZQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. NO LOT NUMBER OR PRODUCT EVALUATION SAMPLE IS AVAILABLE. A DETAILED INVESTIGATION OR BATCH REVIEW CANNOT BE CONDUCTED. THEREFORE THIS EVALUATION WILL BE CLOSED AND WILL BE MONITORED THROUGH OUR POST MARKET PRODUCT MONITORING REVIEW PROCESS. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THE REPORT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    CONSUMER REPORTS ISSUES WITH SKIN UNDER MASS PORTION OF POUCH. STATES AREA STARTED OUT AS REDDENED AND ITCHY, THEN PROGRESSED INTO WEEPING AND REDDENED SKIN UNDER ENTIRE MASS. TREATED AT WOUND CARE CLINIC WITH ANTI-ITCH POWDER, AND UNKNOWN PRESCRIPTION STEROID CREAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762191 ACTIVELIFE® ONE-PIECE POUCH POUCH, COLOSTOMY EZQ CONVATEC INC. 175762

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention ALCOHOL WIPES| AMILODIPINE| BABY SHAMPOO| CRESTOR| HUMIRA| LOSARTIN| NAGELIDINE