BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALPINE REUSABLE LEG BAG LATEX 32 OZ ST

    MDR report key: 2494518 · Received March 16, 2012

    Report

    Report Number
    2125050-2012-00010
    Event Type
    Injury
    Date Received
    March 16, 2012
    Report Date
    February 16, 2012
    Manufacturer
    COLOPLAST MANUFACTURING US LLC
    Product Code
    NNW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLES WERE RETURNED FOR EVALUATION. WITHOUT THE BENEFIT OF ANALYZING THE DEVICE, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    (B)(4).ACCORDING TO THE INFOMATION RECEIVED, A USER REPORTED A URINE BAG WOULD NOT LET HIS FOLEY CATHETER DRAIN. THE USER STATED HE NEEDED TO GO TO THE HOSPITAL BECAUSE OF BACKFLOW OF URINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALPINE REUSABLE LEG BAG LATEX 32 OZ ST URINE BAG NNW COLOPLAST MANUFACTURING US LLC 5596001400

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization