BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 4072199 · Received August 29, 2014

    Report

    Report Number
    9618003-2014-10904
    Event Type
    Injury
    Date Received
    August 29, 2014
    Report Date
    June 27, 2012
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC, INC.
    Product Code
    EZQ
    PMA / PMN Number
    K833625
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 ISSUED APRIL 16, 2014. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION 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)(6) 2011. THE DATA PRESENTED IS FROM THREE DIFFERENT PRODUCT APPLICATIONS. THE REPORT STATES THAT THERE ARE NO SIGNIFICANT TRENDS. IT IS NOTED THAT THERE ARE BLANK AREAS ON THIS FORM, THE INFORMATION WAS NOT PROVIDED IS UNKNOWN.

    Description of Event or Problem · 1

    REPORT RECEIVED INDICATED THAT THE PATIENT HAD A RASH. THIS TRACKWISE RECORD WAS CREATED TO COVER THE RASH ISSUE MENTIONED IN RECORD NUMBER 213668. NO FURTHER INFORMATION WAS PROVIDED AND THE PATIENT OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528078 ACTIVELIFE 1 PC - 1PC DRAINABLE POUCH W/STOMAHESIVE (SH) POUCH, COLOSTOMY EZQ CONVATEC DOMINICAN REPUBLIC, INC. 022771 1K02966

    Patients

    Seq Age Sex Outcome Treatment
    1 Other