BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXI-THERM

    MDR report key: 891029 · Received June 20, 2007

    Report

    Report Number
    891029
    Event Type
    Injury
    Date Received
    June 20, 2007
    Date of Event
    May 24, 2007
    Report Date
    June 13, 2007
    Manufacturer
    CINCINNATI SUB-ZERO PRODUCTS, INC.
    Product Code
    DWJ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    A NON INSULIN DEPENDENT DIABETIC PATIENT WAS UNDERGOING A TRIPLE CORONARY BYPASS PROCEDURE. SHE WAS PLACED ON A HYPOTHERMIA PAD THAT WAS COVERED BY A GEL PAD. PATIENT WAS PREPPED WITH CHLORAPREP. AFTER SURGERY PATIENT SKIN INTEGRITY APPEARED TO BE FINE. TWO DAYS LATER AN 18 X 18 INCH SECOND DEGREE BURN WAS NOTED ON THE PATIENT'S BACK. BURN WAS ALSO PRESENT IN THE FOLD OF THE PATIENT'S SKIN. CAUSE OF THE BURN IS UNCLEAR AT THIS TIME AND IS UNDER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXI-THERM HYPO-HYPERTHERMIA BLANKET DWJ CINCINNATI SUB-ZERO PRODUCTS, INC. * 307102
    2 BLANKETROL II HYPO-HYPERTHERMIA MACHINE DWJ CINCINNATI SUB-ZERO PRODUCTS, INC. 222 *

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R CARDIAC DRUGS