BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESTEEM® + MOLDABLE ONE-PIECE DRAINABLE POUCH

    MDR report key: 6034028 · Received October 17, 2016

    Report

    Report Number
    9618003-2016-00052
    Event Type
    Injury
    Date Received
    October 17, 2016
    Date of Event
    September 20, 2016
    Report Date
    September 27, 2016
    Manufacturer
    CONVATEC INC.
    Product Code
    EZQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. NO LOT NUMBER IS AVAILABLE. A DETAILED INVESTIGATION OR BATCH REVIEW CANNOT BE CONDUCTED. THEREFORE THIS EVALUATION WILL BE CLOSED. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THE REPORT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON OCTOBER 17, 2016. (B)(4). NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    END USER REPORTS SHE IS CUTTING THE OPENING IN A 1 PIECE MOLDABLE POUCH AS THE STOMA IS TOO BIG FOR MOLDING. THIS CAUSED THE STOMA TO BLEED WHEN SHE SAT DOWN OR MOVED. SHE WAS UNABLE TO QUANTIFY THE BLEEDING BUT STATED IT WAS ALL OVER HER CLOTHING AND FLOOR. SHE EXPERIENCED 3 EPISODES OF WHAT SHE DESCRIBED AS "MORE THAN NORMAL BLEEDING" AND SAW HER PRIMARY PHYSICIAN. SHE STATES THAT THE PHYSICIAN WAS ABLE TO SEE THAT THE POUCH WAS CUTTING INTO THE STOMA CAUSING THE BLEEDING, HOWEVER SHE IS UNABLE TO STATE IF THERE IS A LACERATION. SHE WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2016 AND DISCHARGED HOME ON (B)(6) 2016. SHE DOES NOT KNOW WHAT THE ADMITTING DIAGNOSIS WAS. SHE STATES LAB WORK WAS PERFORMED WITH BORDERLINE RESULTS; NO TRANSFUSION WAS NECESSARY. SHE WAS GIVEN SOMETHING INTRAVENOUSLY WHILE HOSPITALIZED BUT DOES NOT KNOW WHAT. SHE WAS PRESCRIBED DOXYCYCLINE AND PREDNISONE WHEN DISCHARGED HOME. SHE REPORTS A HISTORY OF BLEEDING IN THE PAST REQUIRING TRANSFUSIONS BUT SHE DOES NOT KNOW WHAT TYPE OF BRAND OF POUCHING SYSTEM WAS IN USE AT THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685576 ESTEEM® + MOLDABLE ONE-PIECE DRAINABLE POUCH POUCH, COLOSTOMY EZQ CONVATEC INC. 413516

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention AMLODIPINE| FUROSEMIDE| POTASSIUM| SERTRALINE| VARIOUS OVER THE COUNTER (OTC) VITAMINS