BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESTEEM 1PC-1PC DRAINABLE INVISICLOSE DRAINABLE POUCH

    MDR report key: 4101538 · Received August 19, 2014

    Report

    Report Number
    1000317571-2014-10834
    Event Type
    Injury
    Date Received
    August 19, 2014
    Report Date
    July 26, 2012
    Manufacturer
    CONVATEC INC.
    Product Code
    EXE
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    CONVATEC IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO THE FDA 483 ISSUES 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. COULD NOT DETERMINE THAT THERE WAS ANY MANUFACTURING DEFECTS IN PRODUCT. THERE WAS NO OTHER CASES WITHIN THE LAST 12 MONTHS FOR THIS ISSUE AND ICC, THIS IS A LOW LEVEL INCIDENT AND WILL CONTINUE TO BE MONITORED FOR TRENDS.

    Description of Event or Problem · 1

    REPORT PROVIDED BY THE END USER STATES THAT THEY ARE EXPERIENCING RED IRRITATED SKIN UNDER THE APPLIANCE, DESCRIBED AS A 'PLASTER TYPE RASH'. DID NOT MENTION ANY LEAKS. THE PATIENT'S SUBSEQUENT OUTCOME WAS NOT NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500426 ESTEEM 1PC-1PC DRAINABLE INVISICLOSE DRAINABLE POUCH PROTECTOR, OSTOMY EXE CONVATEC INC. 411229 2C02631

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention