BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOVEEN NIGHT BAG 2000 ML, 140 CM

    MDR report key: 1911936 · Received December 1, 2010

    Report

    Report Number
    3003814961-2010-00001
    Event Type
    Injury
    Date Received
    December 1, 2010
    Report Date
    February 4, 2010
    Manufacturer
    COLOPLAST A/S
    Product Code
    FAQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS BEEN REQUESTED BUT AS OF TO DATE NO PRODUCT WAS AVAILABLE FOR TESTING. WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURENCE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    (B)(4). ACCORDING TO THE INFORMATION RECEIVED, AN END USER REPORTED THAT A URINE BAG HAD A BLOCKED INLET. THE INLET OF THE BAG WAS TOO THIN AND IT BLOCKS THE FLOW OF URINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOVEEN NIGHT BAG 2000 ML, 140 CM EXTERNAL URINE BAG FAQ COLOPLAST A/S 2134601001

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention