BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIMBERLY-CLARK PATIENT WARMING

    MDR report key: 679226 · Received February 24, 2006

    Report

    Report Number
    8030647-2006-00008
    Event Type
    Injury
    Date Received
    February 24, 2006
    Date of Event
    December 6, 2005
    Manufacturer
    AVENT S.A. DE C.V.
    Product Code
    DWJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT THE PT WAS INVOLVED IN AN ELEVEN HOUR ENT OPERATIVE SURGICAL PROCEDURE. THE KIMBERLY-CLARK PT WARMING SYSTEM WAS USED THROUGHOUT THE ENTIRE PROCEDURE. POST-OPERATIVELY, THE PT WAS RETURNED TO THE FLOOR AND THREE WOUNDS WERE DISCOVERED BETWEEN THE PT'S SHOULDER BLADES, IN THE AREA WHERE THE DEVICE WAS IN CONTACT WITH THE PT. THE REPORTER MARKED ON THEIR MEDWATCH REPORT THAT THE INCIDENT WAS A PRODUCT PROBLEM AND A PRODUCT USE ERROR AND THAT IT IS REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE. KIMBERLY-CLARK CORPORATION HAS NO FIRST HAND KNOWLEDGE OF THE ALLEGATIONS, BUT IS RELAYING INFO REC'D FROM OUTSIDE SOURCES PURSUANT TO FEDERAL REGULATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIMBERLY-CLARK PATIENT WARMING THERMAL REGULATING SYSTEM DWJ AVENT S.A. DE C.V. 831-01 A4M 1601

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention