BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUR-FIT NATURA 2 PC UROSTOMY POUCH W/ACCUSEAL

    MDR report key: 3820523 · Received April 11, 2014

    Report

    Report Number
    9618003-2014-00034
    Event Type
    Malfunction
    Date Received
    April 11, 2014
    Date of Event
    March 14, 2014
    Report Date
    March 14, 2014
    Manufacturer
    CONVATEC INC.
    Product Code
    EXH
    PMA / PMN Number
    K840166
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. ADDITIONAL FOLLOW-UP INFORMATION WAS RECEIVED ON (B)(4) 2014 STATING, "(B)(6) IS THE PHARMACIST AND HE CALLED TO REPORT THAT END USER WAS A LONG TIME CUSTOMER OF HIS WHO HAD COME INTO THE STORE TO REPORT THAT POUCHES WERE NOT DRAINING FEATURE. END USER DIDN'T REALIZE THAT THE ANTIREFLUX IS IN ALL POUCHES UNTIL HE HAD THIS BOX WHERE URINE WOULD NOT DRAIN TO BOTTOM OF POUCH. HE SAID END USE NOTED IT VERY SOON AFTER APPLYING POUCH AND THEN CHANGED POUCH OUT IMMEDIATELY ONCE ISSUE REALIZED." IT WAS ALSO STATED THAT THERE WERE ATTEMPTS TO CONTACT THE END USER WHICH WERE UNSUCCESSFUL. ADDITIONAL FOLLOW-UP INFORMATION WAS ALSO RECEIVED ON (B)(4) 2014 STATING, "HE STATED HE TRIED ALL 10 IN BOX TO (B)(6). I WOULD IMAGINE THAT IT HAD TO HAVE OCCURRED ALL IN THE SAME NIGHT IF HE KEPT EXPERIENCING IT." PLEASE NOTE: SEPARATE 3500A FORMS HAVE BEEN COMPLETED FOR THE OTHER (9) CASES UNDER (B)(6). MANUFACTURER REPORT#(S) 9618003-2014-00029, 00030, 00031, 00032, 00033, 00035, 00036, 00037, 00038 (REPORT 9 OF 10). NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. A RETURN SAMPLE FOR EVALUATION IS NOT EXPECTED.

    Description of Event or Problem · 1

    A PHARMACIST REPORTED AN END USER STATED THE URINE WOULD NOT FLOW THROUGH THE ANTIREFLUX FEATURE AT NIGHT. (ALL 10 OUT OF A BOX OF 10).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220651 SUR-FIT NATURA 2 PC UROSTOMY POUCH W/ACCUSEAL BAG, URINARY, ILEOSTOMY EXH CONVATEC INC. 401553 3F03036

    Patients

    Seq Age Sex Outcome Treatment
    1