BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EAKIN FISTULA AND WOUND POUCH

    MDR report key: 4309102 · Received November 26, 2014

    Report

    Report Number
    1000317571-2014-00111
    Event Type
    Injury
    Date Received
    November 26, 2014
    Date of Event
    January 1, 2013
    Report Date
    November 4, 2014
    Manufacturer
    CONVATEC LIMITED
    Product Code
    FON
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THE EVENT IS DEEMED TO BE 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. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THE END USER HAD SHORTNESS OF BREATH AND WAS TRANSFERRED TO A CRITICAL CARE UNIT DUE TO THE RELATED POSSIBLE REACTION TO PRODUCT APPROXIMATELY ONE YEAR AGO OCCURRING IN THE (B)(6) OF 2013. IT WAS STATED "THE POSSIBLE INVOLVED PRODUCT WAS THE (B)(4) FISTULA AND WOUND POUCH ".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769604 EAKIN FISTULA AND WOUND POUCH DRAINAGE, WITH ADHESIVE, OSTOMY FON CONVATEC LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| O| R