BEUDAMED
    FDA Adverse Event Injury Summary report: N

    B500 UNIVERSAL BLANKET

    MDR report key: 21055232 · Received January 2, 2025

    Report

    Report Number
    3005857264-2024-00003
    Event Type
    Injury
    Date Received
    January 2, 2025
    Date of Event
    December 2, 2024
    Report Date
    December 31, 2024
    Manufacturer
    AUGUSTINE TEMPERATURE MANAGEMENT LLC
    Product Code
    DWJ
    UDI-DI
    00855913001922
    PMA / PMN Number
    K052392
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    IN SUMMARY, BY FULLY WRAPPING THE PATIENT'S ARM WITH THE WARMING BLANKET AND FOLDING THE ENDS SO THAT THREE LAYERS OF BLANKET COVER ONE PORTION OF THE ARM, THE USER VIOLATED MULTIPLE WARNINGS IN THE IFU AND CAUSED EXCESS HEAT-TRANSFER TO A LOCALIZED AREA ON THE PATIENT'S ARM. PRODUCT MISUSE WAS THE ROOT CAUSE OF THE REPORTED PATIENT INJURY. THE B500 WAS WRAPPED AROUND THE ARM THE LONG WAY, BLACK-TO-BLACK, AND THEN FOLDED OVER THE TOP OF THE ARM. THIS RESULTED IN TRIPLE WATT-DENSITY BLANKET IN CONTACT WITH THE UPPER SURFACE OF THE ARM. IN OUR IFU 1718EN REV K, IN THE PRECAUTIONS SECTION, WE SAY: "DO NOT FOLD THE WARMING BLANKET BLACK-SIDE TO BLACK-SIDE DURING USE, AS LOCALIZED HEAT BUILD-UP MAY OCCUR IN THE OVERLAPPED AREA". THERE IS ALSO THE WARNING: "DO NOT PLACE WARMING BLANKETS UNDER THE PATIENT." THE INJURY WOULD HAVE NOT OCCURRED IF THE BLANKET WOULD HAVE BEEN USED PER THE IFU. THE INJURY DOES NOT MEET OUR THRESHOLD FOR "SERIOUS INJURY" BECAUSE IT IS 2ND DEGREE LESS THAN 10 SQIN. OUR PLAN WAS TO WAIT FOR ADDITIONAL (CLARIFYING) INFORMATION REGARDING MEDICAL INTERVENTION, BEFORE WE FILED THE EMDR. BECAUSE OF THE ADVERSE EVENT FILING DEADLINES, AND US NOT BEING ABLE TO GET ADDITIONAL INFORMATION (PARTLY DUE TO BEING A FOREIGN COUNTRY) WE CANNOT WAIT ANY LONGER FOR ACCURATE INFORMATION. THEREFORE, WE ARE REPORTING THIS INCIDENT WITH THE ONLY INCIDENT INFORMATION WE HAVE.

    Description of Event or Problem · 0

    AS DESCRIBED BY THE REPORTER: "PROCEDURE LENGTH: 70 MINUTES WITH THE UNDERBODY WARMING MATTRESS U102 AND THE UNIVERSAL WARMING BLANKET B500 ATTACHED TO THE TEMPERATURE MANAGEMENT CONTROLLER MULTIPORT WC77. ON REMOVAL OF THE B500, AFTER APPROXIMATELY 60 MINUTES, IT FELT HOTTER THAN THE REST (CONTROLLER 43 °C). PATIENT DISPLAYED [1ST AND] 2ND DEGREE BURN ON THE INSIDE OF THE LEFT ARM WITH BLISTERS MORE THAN 4 X 8 CM IN TWO SPOTS." THE REPORTER IDENTIFIED THE PORTION OF THE 2ND DEGREE BURN TO BE BETWEEN 1-10 SQ IN. PER AUGUSTINE'S INVESTIGATION: THE WARMING BLANKET B500 WAS TESTED ACCORDING TO COMPANY PROCEDURES AND WAS FOUND TO PERFORM PER SPECIFICATION, IT PASSED THE TEMPERATURE UNIFORMITY TEST, THE RESISTANCE TEST AND THE IR TEST. THE CUSTOMER SENT PICTURES OF HOW THE PRODUCT WAS USED DURING THE PROCEDURE. THE CUSTOMER FULLY WRAPPED THE BLANKET AROUND THE PATIENT'S ARM. THE EXCESS LENGTH OF THE BLANKET WAS FOLDED TOGETHER HEATED-SIDE-TO-HEATED-SIDE (BLACK-TO-BLACK), AND THEN DOUBLED BACK OVER THE PATIENT'S ARM RESULTING IN THREE LAYERS OF THE WARMING BLANKET STACKED OVER THE INSIDE PORTION OF THE ARM. THIS TYPE OF WRAPPING/FOLDING IS AGAINST THE IFU. IT RESULTED IN THE WATT DENSITY OF THE HEATER TO BE TRIPLED IN THE OVER-LAPPED AREA. IN OUR IFU 1718EN REV K, IN THE PRECAUTIONS SECTION, WE SAY: "DO NOT FOLD THE WARMING BLANKET BLACK-SIDE TO BLACK-SIDE DURING USE, AS LOCALIZED HEAT BUILD-UP MAY OCCUR IN THE OVERLAPPED AREA". THE INJURY WOULD HAVE NOT OCCURRED IF THE BLANKET WOULD HAVE BEEN USED PER THE IFU. ATM DOES NOT BELIEVE THIS TO BE A SERIOUS INJURY RESULTING IN PERMANENT DAMAGE TO A BODY STRUCTURE, HOWEVER, WE WERE UNABLE TO CONFIRM IF ANY MEDICAL INTERVENTION WAS REQUIRED FOR THE PATIENT. THE REPORT SAID, "TREATMENT OF BURNING." WE MADE MULTIPLE REQUESTS TO THE CUSTOMER AND DISTRIBUTOR FOR NEW INFORMATION, BUT WE DID NOT RECEIVE ANY SPECIFIC DETAILS FOR WHAT THAT INCLUDED. SEE SECTION H11 FOR ADDITIONAL MANUFACTURER'S NARRATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1553787 B500 UNIVERSAL BLANKET UNIVERSAL BLANKET DWJ AUGUSTINE TEMPERATURE MANAGEMENT LLC B500 00855913001922

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Other