BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOTDOG TEMPERATURE MANAGEMENT CONTROLLER MULTIPORT AND 2-PANEL MULTI-POSITION BL

    MDR report key: 19655960 · Received July 1, 2024

    Report

    Report Number
    MW5156877
    Event Type
    Malfunction
    Date Received
    July 1, 2024
    Date of Event
    June 25, 2024
    Report Date
    June 26, 2024
    Manufacturer
    AUGUSTINE TEMPERATURE MANAGEMENT LLC
    Product Code
    DWJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHILE USING THE 3M HOTDOG DURING AN ANTERIOR TOTAL HIP ARTHROPLASTY, PATIENT EXPERIENCED A BURN TO THE LEFT THUMB, WITH BLISTERING, DUE TO CONTACT WITH THE HOTDOG 2-PANEL OVER BODY WARMING BLANKET. THIS IS THE SECOND TIME WE'VE EXPERIENCED AN OVERHEATING ISSUE IN WHICH 3M DID NOTHING ABOUT. THE REP AND THE CORPORATE TEAM WERE DISMISSIVE AND SAID THAT THEIR PRODUCT IS NOT ABLE TO BURN A PATIENT. THIS TIME, THE UNIT CAUSED A BURN AND BLISTERING AND WE WILL NO LONGER USE THIS DEVICE/EQUIPMENT. WARMING BLANKET REF NUMBER: (B)(4), SERIAL NUMBER: (B)(6). HOTDOG CONTROLLER REF NUMBER: (B)(4), SERIAL NUMBER: (B)(6). REFERENCE REPORT: #MW5156876.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447838 HOTDOG TEMPERATURE MANAGEMENT CONTROLLER MULTIPORT AND 2-PANEL MULTI-POSITION BL SYSTEM, THERMAL REGULATING DWJ AUGUSTINE TEMPERATURE MANAGEMENT LLC B105

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Male Other