BEUDAMED
    FDA Adverse Event Injury Summary report: N

    B103 LOWER BODY WARMING BLANKET

    MDR report key: 24157895 · Received January 22, 2026

    Report

    Report Number
    3005857264-2026-00002
    Event Type
    Injury
    Date Received
    January 22, 2026
    Date of Event
    December 23, 2025
    Report Date
    January 22, 2026
    Manufacturer
    AUGUSTINE TEMPERATURE MANAGEMENT
    Product Code
    DWJ
    UDI-DI
    0085591300125
    PMA / PMN Number
    K052392
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    N/A

    Description of Event or Problem · 0

    PATIENT UNDERWENT ELECTIVE FACIAL PLASTIC SURGERY WITH ADJUNCT LASER PROCEDURES PERFORMED IN THE SUPINE POSITION, LASTING APPROXIMATELY 7.5 HOURS. FOLLOWING SURGERY, THE PATIENT REPORTED SIGNIFICANT PAIN IN HER LEFT FOOT/ANKLE. THE AREA WAS EVALUATED AND NO PROBLEMS WERE OBSERVED. OVER THE FOLLOWING DAY, PAIN AND SWELLING WORSENED AND A BLISTER DEVELOPED. THE INJURY WAS DETERMINED TO BE DEEP PARTIAL THICKNESS APPROXIMATELY 1-2 SQ INCHES AT THE MIDFOOT NEAR THE ANTERIOR ANKLE. MEDICAL INTERVENTION WITH A WOUND SPECIALIST WAS REQUIRED TO TREAT THE INJURY. ATM ANALYSIS: THE INJURY WAS REPORTED TO ATM BECAUSE THE PATIENT WAS BEING WARMED WITH A HOTDOG LOWER BODY WARMING BLANKET (SN (B)(6)). THE BLANKET WAS RETURNED TO ATM FOR EVALUATION AND PASSED SAFETY AND FUNCTIONAL TESTS MEETING ALL ESSENTIAL PERFORMANCE REQUIREMENTS. FEEDBACK FROM THE SURGICAL TEAM PROVIDED FURTHER CONTEXT AROUND THE DETAILS OF THE PROCEDURE. THE PATIENT HAD TED HOSE FROM THE FEET TO ABOVE THE KNEE AND ALSO NON-SLIP SOCKS OVER THE FEET. IN ADDITION, THE PATIENT HAD SCD'S ON THE BILATERAL CALVES. THERE WAS A PILLOW UNDER THE KNEES AND THE FEET WERE POSITIONED ON HEEL PADS WITH THE FEET ANGLED STRAIGHT UP. THE BLANKET WAS POSITIONED FROM SLIGHTLY ABOVE THE KNEES DOWNWARD AND EXTENDING BEYOND THE FEET. TRANEXAMIC ACID (THA) WAS ADMINISTERED INTRAVENOUSLY. BASED ON THE POSITIONING OF THE PATIENT AND THE BLANKET (EXTENDING OVER THE TOES), CONTACT BETWEEN THE BLANKET AND THE MIDFOOT WOULD HAVE BEEN MINIMAL AT BEST. AN INSULATATIVE BARRIER OF THE TED HOSE, THE SOCK, AND A SHEET FURTHER RESTRICTED HEAT TRANSFER TO THE FOOT AREA. THE BLANKET TESTED WITHIN SPECIFICATIONS, SO AN ISOLATED THERMAL INJURY DOES NOT SEEM POSSIBLE, ESPECIALLY WHILE ADJACENT AREAS (E.G. THE TOES) BORE THE WEIGHT OF THE BLANKET AND REMAINED UNAFFECTED. THE MOST LIKELY ROOT CAUSE WAS THE TIGHT TED HOSE IN COMBINATION WITH VASOCONSTRICTION FROM THX THROUGHOUT THE 7.5 HOUR PROCEDURE CAUSED A PRESSURE INJURY ON THE BONY PORTION OF THE MID-FOOT. WARMING INCREASES THE METABOLIC RATE OF THE TISSUE, SO IT CAN ACCELERATE THE TIME IT TAKES FOR A PRESSURE INJURY TO OCCUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217465 B103 LOWER BODY WARMING BLANKET B103 LOWER BODY WARMING BLANKET DWJ AUGUSTINE TEMPERATURE MANAGEMENT B103 0085591300125

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female Other