BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMALATOR

    MDR report key: 12969128 · Received December 9, 2021

    Report

    Report Number
    1000150265-2021-00004
    Event Type
    Malfunction
    Date Received
    December 9, 2021
    Date of Event
    October 28, 2021
    Report Date
    October 28, 2021
    Manufacturer
    FABRICACION Y MANUFACTURAS DE MEXICO S.A.DE C.V.
    Product Code
    IRQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    CUSTOMER INFORMED ABOUT A PATIENT SUSTAINED A SECOND DEGREE BURN WITH 15MM INTACT BLISTER ON RIGHT ANKLE INSTEP, THE NEXT DAY AFTER THE TREATMENT PROVIDED. CUSTOMER CONFIRMED THAT THE THERMALATOR UNIT WAS OPERATING WITHIN SPECIFIED TEMPURATURE RANGE AS PER INSTRUCTION FOR USE. DURING THE FOLLOW UP, CUSTOMER INFORMED THAT THE PATIENT WAS TREATED USING THE FIRST AID KIT, NO FURTHER TREATMENT WAS REQUIRED. THE THERMALATOR MODEL NUMBER USED DURING THE TREATMENT WAS IDENTIFIED AS T-12-M.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1863751 THERMALATOR MOIST HEAT THERAPY IRQ FABRICACION Y MANUFACTURAS DE MEXICO S.A.DE C.V. T-12-M

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Male