BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONVEEN STANDARD 1500 ML URINE BAG/ 1 SET OF STRAPS

    MDR report key: 1911809 · Received December 1, 2010

    Report

    Report Number
    9610694-2010-00018
    Event Type
    Malfunction
    Date Received
    December 1, 2010
    Report Date
    October 23, 2009
    Manufacturer
    COLOPLAST A/S
    Product Code
    FAQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE SAMPLE WAS RETURNED AND TESTED REGARDING THE FLOW OF URINE INTO THE BAG. IT WAS OBSERVED THAT THE URINE DOES NOT FLOW INTO THE BAG. IT APPEARS THAT THE GRV IS GLUED WITH THE FOILS OF THE BAG COMPLETELY. BASED UPON THE PRODUCT EVALUATION, THE COMPLAINT IS CONFIRMED AS REPORTED.

    Description of Event or Problem · 1

    PATIENT IDENTIFIER: (B)(6). DATE OF EVENT: BEST ESTIMATE IS (B)(6) 2009. ACCORDING TO THE INFORMATION RECEIVED, A URINE BAG WAS WELDED AT THE TOP (A 3CM WIDTH STRIP WELD IS LOCATED AT THE TOP OF THE BAG) SO THE LIQUID CANNOT GO INTO THE BAG. THE LIQUID STAYED BLOCKED AT THE TOP OF THE BAG AND REMAINED IN THE INLET TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONVEEN STANDARD 1500 ML URINE BAG/ 1 SET OF STRAPS URINE BAGE FAQ COLOPLAST A/S 0506261001 348942

    Patients

    Seq Age Sex Outcome Treatment
    1