BEUDAMED
    FDA Adverse Event Injury Summary report: N

    U102 HOTDOG UNDER BODY WARMING MATTRESS 127 CM ( 50")

    MDR report key: 21223255 · Received January 23, 2025

    Report

    Report Number
    3005857264-2025-00006
    Event Type
    Injury
    Date Received
    January 23, 2025
    Date of Event
    May 23, 2023
    Report Date
    January 23, 2025
    Manufacturer
    AUGUSTINE TEMPERATURE MANAGEMENT
    Product Code
    DWJ
    UDI-DI
    00855913001527
    PMA / PMN Number
    K092807
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ALTHOUGH THE REPORTER DESCRIBES THIS AS A THERMAL BURN, ATM SUSPECTS IT IS A SKIN REACTION RELATED TO CHEMICALS DUE TO THE LOCATION OF THE REDNESS AND THE PATTERN OF THE REDNESS. ALSO, PRODUCT MISUSE WAS A CONTRIBUTING FACTOR TO THE REPORTED PATIENT INJURY. THE PRODUCT WAS USED IN VIOLATION OF THE PRECAUTION "THE RISK OF SKIN IRRITATION CAUSED BY POOLING OF SURGICAL PREP SOLUTIONS UNDER THE PATIENT MAY INCREASE WITH WARMING; ENSURE THAT SURGICAL PREP SOLUTION INSTRUCTIONS FOR USE ARE FOLLOWED". WARMTH COULD HAVE CONTRIBUTED TO THE INJURY.

    Description of Event or Problem · 0

    AS DESCRIBED BY THE REPORTER THAT NOTIFIED AUGUSTINE TEMPERATURE MANAGEMENT'S DISTRIBUTOR IN AUSTRALIA: "HIP REPLACEMENT SURGERY - TIME: 1.5-2 HOURS. PATIENT WAS NOT NOTICED TO HAVE THE BURN AS THEY HAD SPINAL AND GA ONBOARD- RECOVERY STAFF DISCOVERED THE BURN ON HANDOVER OF THE PATIENT." THE INJURY IS DESCRIBED AS: "2ND DEGREE BURN TO THE LEFT HIP AND ABDOMINAL AREA WITH A SIZE OF 1SQ IN TO 10 SQ INCHES.". THE REPORTER SENT IMAGES AND MENTIONED: "PATIENT REQUIRED ADDITIONAL CARE NEEDS- STAY IN ICU, REVIEW FROM BURNS UNIT AND GENERAL SURGEON." NO ADDITIONAL DETAILS ON THE FOLLOW-UP CARE WERE PROVIDED. ACCORDING TO THE REPORTER, THE INJURY "DID NOT RESULT IN PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE." PER AUGUSTINE'S INVESTIGATION: THE UNDERBODY MATTRESS U102 S# (B)(6) WAS TESTED ACCORDING TO COMPANY PROCEDURES AND WAS FOUND TO PERFORM PER SPECIFICATION AND PASSED ALL SAFETY AND FUNCTIONAL TESTS. VISUAL INSPECTION SHOWS THE MATTRESS WITH A LOT OF FOLDS AND WRINKLES BUT IS OTHERWISE FREE OF ANY DAMAGES OR ABNORMALITIES; THIS DID NOT ADVERSELY AFFECT THE PERFORMANCE OF THE DEVICE. PER THE IMAGES SENT, THE AREAS ON THE PATIENT THAT SHOW SIGNS OF REDNESS AND BLISTERS ARE MAINLY IN THE SKIN CREASE AREAS NEAR THE ABDOMEN AND THE CREASES NEAR THE HIP FLEXOR. THESE AREAS WERE NOT TOUCHED BY ATM'S WARMING MATTRESS OR ANY WARMING DEVICE. THE MATTRESS OVERLAY WAS CONFIRMED TO BE FLAT ON THE OPERATING TABLE AND NOT FOLDED UP AGAINST THE PATIENT; A BOLSTER WAS USED AT THE ILIAC CREST AND ANOTHER BOLSTER WAS USED AT THE BACK OF THE PATIENT PLUS THEY USED AN UPPER ARM SUPPORT. ALTHOUGH THE REPORTER DESCRIBES THIS AS A THERMAL BURN, ATM SUSPECTS IT IS AN ADVERSE SKIN REACTION RELATED TO CHEMICALS DUE TO THE LOCATION OF THE REDNESS AND THE STREAKING PATTERN OF THE REDNESS AND BLISTERING. IN OUR IFU 2064 IN PRECAUTIONS WE ADVISE "THE RISK OF SKIN IRRITATION CAUSED BY POOLING OF SURGICAL PREP SOLUTIONS UNDER THE PATIENT MAY INCREASE WITH WARMING; ENSURE THAT SURGICAL PREP SOLUTION INSTRUCTIONS FOR USE ARE FOLLOWED". HEAT COULD HAVE CONTRIBUTED TO THE ADVERSE REACTION. THE CUSTOMER ASKED IN THE INCIDENT REPORT FORM, "DOES IT HAVE THE ABILITY TO WARM A LIQUID TO A DEGREE THAT COULD SUSTAIN BURNS?" THE ANSWER IS 'NO.' THE MATTRESS WARMS TO A MAX HEAT SETTING OF 40C. THAT IS NOT WARM ENOUGH TO CAUSE THERMAL INJURY ON PERFUSED TISSUE. AS LONG AS THERE WAS SUFFICIENT BLOOD FLOW TO THE WARMED TISSUE, THE ONLY EXPLANATION FOR THE INJURY IS AN ADVERSE REACTION TO POOLING CHEMICALS. IT ALSO CORRESPONDS WITH THE PATTERN AND LOCATION OF THE INJURY SHOWN IN THE PICTURES. ATM HAS DECIDED TO FILE THIS EMDR, SINCE NO ADDITIONAL DETAILS/ OR CLARIFICATION WAS OBTAINED IN REGARD TO THE MEDICAL INTERVENTION REQUIRED BY THIS CUSTOMER. SEE SECTION H11 FOR ADDITIONAL MANUFACTURER NARRATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    952590 U102 HOTDOG UNDER BODY WARMING MATTRESS 127 CM ( 50") ELECTRIC HEATING PAD DWJ AUGUSTINE TEMPERATURE MANAGEMENT U102 00855913001527

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Other| R