BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVELIFE® ONE-PIECE DRAINABLE PRE-CUT

    MDR report key: 6046260 · Received October 21, 2016

    Report

    Report Number
    9618003-2016-00053
    Event Type
    Injury
    Date Received
    October 21, 2016
    Report Date
    October 5, 2016
    Manufacturer
    CONVATEC INC.
    Product Code
    EZQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A SERIOUS INJURY. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THE REPORT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS NOT ASSOCIATED WITH A PRODUCT MALFUNCTION. THE COMPLAINT/INCIDENCE DATA-POST MARKET DATA ANALYSIS (TREND ANALYSIS), CLINICAL REVIEW, ROOT CAUSE ANALYSIS AND RISK ASSESSMENT INDICATE A CONSISTENT RATE OF COMPLAINTS AS A RESULT OF SKIN COMPLICATIONS WHICH ARE CAUSED BY A VARIETY OF EXTERNAL FACTORS NOT RELATED TO THE DESIGN, MATERIALS, AND/OR PROCESSES OF THE PRODUCT. NO FURTHER ACTIONS ARE REQUIRED, AND THIS COMPLAINT WILL BE CLOSED. PRODUCT MONITORING REVIEWS WILL MONITOR FOR PRODUCT TRENDS IF THIS ISSUE WERE TO REOCCUR. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    END USER REPORTS SHE DEVELOPED REDNESS, ITCHING, AND SKIN WEEPING BENEATH THE TAPE COLLAR ABOUT 3 MONTHS AGO. SHE SAW A DERMATOLOGIST WHO PRESCRIBED A CREAM. SHE STATES SHE CUTS THE TAPE COLLAR OFF BUT STILL HAS SOME SKIN REDNESS THAT IMPROVES WITH THE MEDICATION BUT NEVER GOES AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698708 ACTIVELIFE® ONE-PIECE DRAINABLE PRE-CUT POUCH, COLOSTOMY EZQ CONVATEC INC. 022764

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention