BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 4121360 · Received September 19, 2014

    Report

    Report Number
    9618003-2014-11645
    Event Type
    Injury
    Date Received
    September 19, 2014
    Report Date
    May 17, 2013
    Manufacturer
    CONVATEC INC.
    Product Code
    EZQ
    PMA / PMN Number
    K780454
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 (B)(4) 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 FORM A TRENDING REPORT OF EVALUATIONS 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

    REPORT RECEIVED INDICATED THE PT HAD A PERISTOMAL 25 MILLIMETER, SUPERFICIAL, WEEPY OPENING IN THE SKIN AT 06:00 O'CLOCK. THE PT COULD NOT APPROXIMATE HOW LONG AREA HAD BEEN THERE. NO FURTHER INFORMATION WAS PROVIDED AND THE PT OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583490 ACTIVELIFE 1 PC - 1 PC DRAINABLE POUCH W/STOMAHESIVE (SH) POUCH, COLOSTOMY EZQ CONVATEC INC. 125341 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention