BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIGHTY BLISS LARGE ELECTRIC HEATING PAD

    MDR report key: 16103812 · Received January 4, 2023

    Report

    Report Number
    MW5114179
    Event Type
    Malfunction
    Date Received
    January 4, 2023
    Date of Event
    July 20, 2022
    Report Date
    January 3, 2023
    Manufacturer
    WHELE, LLC.
    Product Code
    IRT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    HEATING PAD WILL NOT GET WARM AND THEN WILL SUDDENLY GET SUPER HOT. THE PAD'S CONTROLS WILL GET VERY HOT TO THE TOUCH. OTHER MODELS WERE RECALLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131991 MIGHTY BLISS LARGE ELECTRIC HEATING PAD PAD, HEATING, POWERED IRT WHELE, LLC. NA-H21B 210201

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female FISH OIL.