BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONVEEN CONTOUR LEG BAG

    MDR report key: 4174363 · Received October 7, 2014

    Report

    Report Number
    MW5038583
    Event Type
    Malfunction
    Date Received
    October 7, 2014
    Date of Event
    September 30, 2014
    Report Date
    October 7, 2014
    Manufacturer
    COLOPLAST CORPORATION
    Product Code
    FAQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2014, REPORTER RECEIVED AN EMAIL FROM ACCOUNT MANAGEMENT AT COLOPLAST CORPORATION WITH A LETTER OF NOTIFICATION FOR THE CORRECTIVE AND REMOVAL ACTION FOR THE CONVEEN CONTOUR LEG BAG. EFFECTIVE (B)(6) 2014, COLOPLAST IS PERFORMING A CORRECTIVE AND REMOVAL ACTION ON THE FOLLOWING PRODUCT NUMBERS AND LOT NUMBERS DUE TO POTENTIAL LEAKAGE FROM THE BAG SEAM WHEN FILLED. REPORTER CANNOT IDENTIFY EVIDENCE CONFIRMING THAT THE FDA IS AWARE. PRODUCT NUMBER 5170. LOT NUMBERS: 3880261, 3932929, 3940329, 3949825, 3968997, 3997778, 4019572, 4047072, 4056422, 4073930, 4092991. PRODUCT NUMBER 5171. LOT NUMBERS: 3997492, 4006822, 405623, 4100228. PRODUCT NUMBER 5174. LOT NUMBERS: 3880268, 3932933, 3940332, 3949828, 3969002, 3997782, 40195721, 4047075, 4056428, 4073934, 4092990. (B)(4). FREQUENCY: PRN/AS NEEDED, ROUTE: URINARY TRACT. DIAGNOSIS OR REASON FOR USE: URINARY INCONTINENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627755 CONVEEN CONTOUR LEG BAG URINARY DRAINAGE BAG, LEG FAQ COLOPLAST CORPORATION 3932929
    627756 CONVEEN CONTOUR LEG BAG URINARY DRAINAGE BAG, LEG FAQ COLOPLAST CORPORATION 3940329
    627757 CONVEEN CONTOUR LEG BAG URINARY DRAINAGE BAG, LEG FAQ COLOPLAST CORPORATION 3949825
    627758 CONVEEN CONTOUR LEG BAG URINARY DRAINAGE BAG, LEG FAQ COLOPLAST CORPORATION 4019572
    627759 CONVEEN CONTOUR LEG BAG URINARY DRAINAGE BAG, LEG FAQ COLOPLAST CORPORATION 4047072
    627760 CONVEEN CONTOUR LEG BAG URINARY DRAINAGE BAG, LEG FAQ COLOPLAST CORPORATION 4092991
    627761 CONVEEN CONTOUR LEG BAG URINARY DRAINAGE BAG, LEG FAQ COLOPLAST CORPORATION 3997492
    627762 CONVEEN CONTOUR LEG BAG URINARY DRAINAGE BAG, LEG FAQ COLOPLAST CORPORATION 4006822
    627763 CONVEEN CONTOUR LEG BAG URINARY DRAINAGE BAG, LEG FAQ COLOPLAST CORPORATION 3880268
    627764 CONVEEN CONTOUR LEG BAG URINARY DRAINAGE BAG, LEG FAQ COLOPLAST CORPORATION 3932933
    627765 CONVEEN CONTOUR LEG BAG URINARY DRAINAGE BAG, LEG FAQ COLOPLAST CORPORATION 3949828
    627766 CONVEEN CONTOUR LEG BAG URINARY DRAINAGE BAG, LEG FAQ COLOPLAST CORPORATION 3997782
    627767 CONVEEN CONTOUR LEG BAG URINARY DRAINAGE BAG, LEG FAQ COLOPLAST CORPORATION 4047075
    627768 CONVEEN CONTOUR LEG BAG URINARY DRAINAGE BAG, LEG FAQ COLOPLAST CORPORATION 4073934
    627769 CONVEEN CONTOUR LEG BAG URINARY DRAINAGE BAG, LEG FAQ COLOPLAST CORPORATION 4092990
    627850 CONVEEN CONTOUR LEG BAG URINARY DRAINAGE BAG, LEG FAQ COLOPLAST CORPORATION 3880261
    627851 CONVEEN CONTOUR LEG BAG URINARY DRAINAGE BAG, LEG FAQ COLOPLAST CORPORATION 3968997
    627852 CONVEEN CONTOUR LEG BAG URINARY DRAINAGE BAG, LEG FAQ COLOPLAST CORPORATION 3997778
    627853 CONVEEN CONTOUR LEG BAG URINARY DRAINAGE BAG, LEG FAQ COLOPLAST CORPORATION 4056422
    627854 CONVEEN CONTOUR LEG BAG URINARY DRAINAGE BAG, LEG FAQ COLOPLAST CORPORATION 4073930
    627855 CONVEEN CONTOUR LEG BAG URINARY DRAINAGE BAG, LEG FAQ COLOPLAST CORPORATION 405623
    627856 CONVEEN CONTOUR LEG BAG URINARY DRAINAGE BAG, LEG FAQ COLOPLAST CORPORATION 4100228
    627857 CONVEEN CONTOUR LEG BAG URINARY DRAINAGE BAG, LEG FAQ COLOPLAST CORPORATION 3940332
    627858 CONVEEN CONTOUR LEG BAG URINARY DRAINAGE BAG, LEG FAQ COLOPLAST CORPORATION 3969002
    627859 CONVEEN CONTOUR LEG BAG URINARY DRAINAGE BAG, LEG FAQ COLPLAST CORPORATION 4019574
    627860 CONVEEN CONTOUR LEG BAG URINARY DRAINAGE BAG, LEG FAQ COLOPLAST CORPORATION 4056428

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR