BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVISER AUTOVALVE IAP MONITORING DEVICE WITH E

    MDR report key: 4338159 · Received December 10, 2014

    Report

    Report Number
    1049092-2014-00613
    Event Type
    Injury
    Date Received
    December 10, 2014
    Date of Event
    November 11, 2014
    Report Date
    November 13, 2014
    Manufacturer
    CONVATEC, INC.
    Product Code
    FEN
    PMA / PMN Number
    EXEMP;T
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A SERIOUS INJURY. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CRITICAL CARE EDUCATOR COLLEEN RYAN, REGISTERED NURSE REPORTS THAT THE GREEN VALVE IN THE AUTOVALVE DID NOT DEFLATE WITH ONE UNIT OUT OF A CASE OF 10. THE REGISTERED NURSE CARING FOR THE PATIENT STATES THAT THE PATIENT WAS VOIDING AROUND THE FOLEY CATHETER RATHER THAN THROUGH THE CATHETER. THE REGISTERED NURSE ATTEMPTED TO IRRIGATE THE FOLEY CATHETER AND THEN CHANGED THE FOLEY CATHETER, BUT THE URINE CONTINUED TO DRAIN AROUND THE CATHETER RATHER THAN THROUGH THE CATHETER. THE REGISTERED NURSE REMOVED THE ABVISER AND THE URINE THEN STARTED TO DRAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797274 ADVISER AUTOVALVE IAP MONITORING DEVICE WITH E FEN CONVATEC, INC. ABV321 140437

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention