BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SNUGGLE WARM CONVECTIVE WARMING SYSTEM

    MDR report key: 31853 · Received February 23, 1996

    Report

    Report Number
    31853
    Event Type
    Injury
    Date Received
    February 23, 1996
    Date of Event
    February 14, 1996
    Report Date
    February 21, 1996
    Manufacturer
    RESPIRATORY SUPPORT PRODUCTS, INC.
    Product Code
    DWJ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WARMER PLACED ON LOWER BODY, PER PHYSICIAN ORDER DURING THORACO-ABDOMINAL AORTIC ANEURYSM REPAIR. AT THE END OF THE CASE, KNEES NOTED TO BE BLISTERED, RIGHT BIG TOE REDDENED. CONTRAINDICATIONS ARE IN INSTRUCTIONS INCLUDED IN BOX MACHINE SHIPPED IN. NOT FOUND UNTIL AFTER INCIDENT. NOT IN OPERATOR'S MANUAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SNUGGLE WARM CONVECTIVE WARMING SYSTEM WARMING SYSTEM DWJ RESPIRATORY SUPPORT PRODUCTS, INC. SW-2001

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention