BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOTDOG PATIENT WARMING SYSTEM

    MDR report key: 12129529 · Received July 7, 2021

    Report

    Report Number
    MW5102305
    Event Type
    Injury
    Date Received
    July 7, 2021
    Date of Event
    May 26, 2021
    Report Date
    July 2, 2021
    Manufacturer
    AUGUSTINE TEMPERATURE MANAGEMENT LLC
    Product Code
    DWJ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A (B)(6) YEAR OLD PATIENT DEVELOPED BLISTERS AND FULL THICKNESS BURN TO LEFT BUTTOCK FOLLOWING A UROLOGIC ROBOTIC ASSISTED LAPAROSCOPIC SURGERY IN WHICH SHE WAS POSITIONED ON LEFT LATERAL SIDE LAYING ON A HOTDOG PATIENT WARMING MATTRESS. TOTAL SURGERY TIME = 124 MIN. SHE HAS REQUIRED TREATMENT AND MULTIPLE DEBRIDEMENTS BY WOUND CARE AND PLASTIC SURGERY SPECIALISTS. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1026857 HOTDOG PATIENT WARMING SYSTEM SYSTEM, THERMAL REGULATING DWJ AUGUSTINE TEMPERATURE MANAGEMENT LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Other| R