BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVELIFE 1 PC-1PC DRAINABLE POUCH W/ DURAHESIVE

    MDR report key: 4122249 · Received September 17, 2014

    Report

    Report Number
    9618003-2014-10996
    Event Type
    Injury
    Date Received
    September 17, 2014
    Report Date
    October 9, 2012
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC, INC.
    Product Code
    EZQ
    PMA / PMN Number
    K780454
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONVATEC IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO THE FDA 483 ISSUED APRIL 16, 2014. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFO RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. BRAND NAME: UNK. ACTIVELIFE 1 PC - 1 PC DRAINABLE POUCH W/ DURAHESIVE (DH) PLUS. ANALYSIS IS TAKEN FROM A TRENDING REPORT OF EVALUATION OR ADVERSE EVENTS FINALIZED MAY 2011. THE DATA PRESENTED IS FROM THREE DIFFERENT PRODUCT APPLICATIONS. THE REPORT STATES THAT THERE ARE NO SIGNIFICANT TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PT DEVELOPED A RASH UNDER TAPE COLLAR WITHIN ONE DAY OF APPLICATION. USES COMPETITIVE BRAND STOMAHESIVE POWDER AND PREP UNDER WAFER. RETURNED TO PRODUCT USED PREVIOUSLY WITH NO ISSUES (B)(4). RASH RESOLVING. NO ADDITIONAL INFO WAS PROVIDED. PT OUTCOME IS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575768 ACTIVELIFE 1 PC-1PC DRAINABLE POUCH W/ DURAHESIVE POUCH, COLOSTOMY EZQ CONVATEC DOMINICAN REPUBLIC, INC. 400598

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention