BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONVEEN CONTOUR URINEBAGS, 600ML

    MDR report key: 1220092 · Received October 31, 2008

    Report

    Report Number
    9610694-2008-00007
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Report Date
    October 1, 2008
    Manufacturer
    COLOPLAST A/S
    Product Code
    FAQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURN OF THE DEVICE HAS BEEN REQUESTED; HOWEVER, IT IS UNCLEAR IF THE DEVICE WILL BE AVAILABLE. WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BE RECEIVED, AN ADDENDUM TO THIS REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AS REPORTED BY AN END USER, A URINE BAG WAS DEFECTIVE WITH A LEAKY NON-RETURN VALVE. USER STATES THE BAG DOESN'T SEEM TO HAVE AN ANTI-REFLUX VALVE. USER REPORTS OCCASIONAL UTIS. USER REPORTS HAVING 5 BAGS WITH SIMILAR ISSUES: LOT #900374, 1009289, 1085242, 1466039, AND 1467121. BEST ESTIMATE OF DATE OF EVENT IS 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONVEEN CONTOUR URINEBAGS, 600ML NONE FAQ COLOPLAST A/S 0517001400 1467121

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention