BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 4132809 · Received September 29, 2014

    Report

    Report Number
    9618003-2014-11200
    Event Type
    Injury
    Date Received
    September 29, 2014
    Report Date
    December 18, 2012
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC, INC.
    Product Code
    EZQ
    PMA / PMN Number
    K833625
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 04/16/2014. 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)(4) 2011. THE DATA PRESENTED IS FROM (B)(4) DIFFERENT PRODUCT APPLICATIONS. THE REPORT STATES THAT THERE ARE NO SIGNIFICANT TRENDS.

    Description of Event or Problem · 1

    PER THE THIRD PARTY DISTRIBUTION CENTER, THE ATTACHED LETTER SAYS THE HARDNESS OF THE POUCH'S FLANGE CAUSED THE END USER'S SKIN TO BLEED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606493 ACTIVELIFE 1 PC - 1 PC DRAINABLE POUCH W/STOMAHESIVE (SH) EZQ CONVATEC DOMINICAN REPUBLIC, INC. 022752 0J01517

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other