BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATURA INVISI STD CLR BSF WF45MM

    MDR report key: 5138781 · Received October 8, 2015

    Report

    Report Number
    9618003-2015-30384
    Event Type
    Injury
    Date Received
    October 8, 2015
    Date of Event
    December 10, 2013
    Report Date
    February 27, 2014
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC, INC
    Product Code
    EZQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONVATEC IS SUBMITTING THIS REPORT AS A RESULT OF ACTIVITIES RELATED TO CONVATEC REMEDIATION PROTOCOL (B)(4). CONVATEC IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21CFR PART 803. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT WILL BE FILED ON A SUPPLEMENTAL REPORT (MEDWATCH 3500A). EVALUATION CONCLUSIONS ARE REFLECTED IN THE CODES.

    Description of Event or Problem · 1

    SON CALLED TO REPORT HIS MOTHERS STOMA WAS CUT DUE TO A ROUGH SPOT ON THE FILTER ON THE INSIDE OF THE POUCH. SON DESCRIBES THE BLEEDING AS OCCURRING AT 10 PM AND STOPPED BY MIDNIGHT. ENCOURAGED FOLLOW-UP WITH HEALTHCARE PROVIDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665257 NATURA INVISI STD CLR BSF WF45MM POUCH, COLOSTOMY EZQ CONVATEC DOMINICAN REPUBLIC, INC 411360 3C02659

    Patients

    Seq Age Sex Outcome Treatment
    1