BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVELIFE 1 PC - 1 PC DRAINABLE POUCH W. DURA

    MDR report key: 4181375 · Received September 16, 2014

    Report

    Report Number
    1049092-2014-11751
    Event Type
    Injury
    Date Received
    September 16, 2014
    Report Date
    June 17, 2013
    Manufacturer
    CONVATEC INC
    Product Code
    EZQ
    PMA / PMN Number
    K833625
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, 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 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. IT IS NOTED THAT THERE ARE BLANK AREAS ON THIS FORM, THE INFORMATION WAS NOT PROVIDED OR IS UNK. THE RETURNED SAMPLE CONFIRMED INCORRECT PRODUCT IN THE MARKET UNIT. EVENT (B)(6) HAS BEEN RAISED FOR INVESTIGATION.

    Description of Event or Problem · 1

    PT REPORTED THAT 2 BOXES OF 5 POUCHES PRECUT TO 25MM PRODUCT WERE ACTUALLY PRECUT TO 32 MM SIZE. SAME LOT NUMBER. THE END USER SUBSEQUENT OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571427 ACTIVELIFE 1 PC - 1 PC DRAINABLE POUCH W. DURA POUCH COLOSTOMY EZQ CONVATEC INC 175779 2L01069

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other