BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVELIFE 1 PC-1PC DRAINABLE POUCH W/ STOMAHESIVE (SH)

    MDR report key: 4121349 · Received September 19, 2014

    Report

    Report Number
    9618003-2014-11367
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    February 11, 2013
    Report Date
    February 11, 2013
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC, INC.
    Product Code
    EZQ
    PMA / PMN Number
    K833625
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONVATEC IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO THE FDA 483 ISSUES (B)(4) 2014. DEVICE (S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NO DIAGNOSIS. ANY ADDITIONAL INFO RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. ANALYSIS IS TAKEN FROM A TRENDING REPORT OF EVALUATIONS OR ADVERSE EVENTS FINALIZED (B)(4) 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

    PER THE END USER, RED, ITCHING RASH BENEATH THE TAPE BORDER. NO FURTHER INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583757 ACTIVELIFE 1 PC-1PC DRAINABLE POUCH W/ STOMAHESIVE (SH) POUCH, COLOSTOMY EZQ CONVATEC DOMINICAN REPUBLIC, INC. 022771 2L01705

    Patients

    Seq Age Sex Outcome Treatment
    1 Other