BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATHETER 2WAY 5CC CH12

    MDR report key: 2370106 · Received June 9, 2010

    Report

    Report Number
    2183558-2010-00022
    Event Type
    Injury
    Date Received
    June 9, 2010
    Date of Event
    May 1, 2010
    Report Date
    May 13, 2010
    Manufacturer
    COLOPLAST MANUFACTURING US, LLC
    Product Code
    KOD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT AVAILABLE TO BE RETURNED. 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, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ACCORDING TO THE INFORMATION RECEIVED, A COMPLAINT WAS RECEIVED REGARDING A MALFUNCTION. THE BALLOON ON THE CATHETER WOULD NOT DEFLATE. CUSTOMER HAD TO GO TO THE EMERGENCY ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATHETER 2WAY 5CC CH12 INDWELLING CATHETER, PRODUCT CODE: KOD KOD COLOPLAST MANUFACTURING US, LLC UC25121400

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention