BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENFLOW

    MDR report key: 2236774 · Received August 30, 2011

    Report

    Report Number
    3006095475-2011-00003
    Event Type
    Injury
    Date Received
    August 30, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 30, 2011
    Manufacturer
    ENGINIVITY, LLC.
    Product Code
    LGZ
    PMA / PMN Number
    K060537
    Removal / Correction Number
    2242551-06/15/11-005-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO MFR FOR EVAL. THIS UNIT IS UNDER RECALL AS REPORTED UNDER CORRECTION / REMOVAL REPORTING NUMBER 2242551-06/15/11-005-R AND HAS FAILED IN THE SAME MANNER ASD REPORTED IN MFR REPORT #3006095475-2011-00001.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BURN WAS DISCOVERED ON A PT FOLLOWING A CASE WHERE AN ENFLOW INFUSION FLUID WARMER WAS USED. THE PT WAS ANESTHETIZED DURING THE PROCEDURE. THE BURN WAS LOCATED ON THE UPPER RIGHT THIGH NEAR THE FRONT WHERE THE WARMER HAD BEEN SITTING ON TOP OF A DRAPE ON TOP OF THE PT. IT WAS A SECOND DEGREE BURN APPROX 2 INCHES BY 4 INCHES. THE BURN WAS TREATED WITH BACITRACIN OINTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENFLOW THERMAL INFUSION FLUID WARMER LGZ ENGINIVITY, LLC. 980105VS

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention