BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 4012457 · Received July 31, 2014

    Report

    Report Number
    9618003-2014-10013
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    April 29, 2011
    Report Date
    May 5, 2011
    Manufacturer
    CONVATEC DOM. REPUBLIC INC
    Product Code
    EZQ
    PMA / PMN Number
    K833625
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 (B)(4) ISSUED (B)(4) 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. THE RETAINED PRODUCT WAS EVALUATED AND THE EVALUATION RESULTS ARE AS FOLLOWS: THE SAMPLES WERE VISUALLY INSPECTED AND ALL SAMPLES APPEARED TO BE IN NORMAL CONDITION. LEAK TESTING WAS PERFORMED AND PASSES THE ESTABLISHED SPECIFICATION. IT IS NOTED THAT THERE ARE BLANK AREAS ON THIS FORM, THE INFO WAS NOT PROVIDED OR IS UNK.

    Description of Event or Problem · 1

    REPORT RECEIVED INDICATED THE PT EXPERIENCED A RED PERISTOMAL RASH UNDERNEATH THE ENTIRE MASS. PT EXPERIENCED THIS CONDITION FOR AN UNK PERIOD PRIOR TO COMPLAINT RECEIPT. PT OUTCOME WAS NOT NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447323 ACTIVELIFE 1PC - 1 PC DRAINABLE POUCH W/ STOMAHESIVE(SH) POUCH, COLOSTOMY EZQ CONVATEC DOM. REPUBLIC INC 022771 1B02916

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention