BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIGHTY BLISS ELECTRIC HEATING PAD

    MDR report key: 16337115 · Received February 8, 2023

    Report

    Report Number
    MW5114804
    Event Type
    Injury
    Date Received
    February 8, 2023
    Date of Event
    November 3, 2022
    Report Date
    February 5, 2023
    Manufacturer
    WHELE LLC.
    Product Code
    IRT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NH, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I WAS USING THE HEATING PAD ON MY STOMACH. WHEN I TOOK IT OFF I HAD A SMALL BURN / RASH IN ONE SECTION OF MY STOMACH. THE AFFECTED AREA WAS PROBABLY A 3" X 3" SQUARE. IT CONTINUED TO HURT FOR ABOUT A WEEK AND I WAS UNABLE TO WEAR JEANS OR TIGHT FITTING PANTS DURING THIS TIME BECAUSE OF THE LOCATION. THE RASH TOOK ABOUT TWO WEEKS TO HEAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    997438 MIGHTY BLISS ELECTRIC HEATING PAD PAD, HEATING, POWERED IRT WHELE LLC. NA H1121B 210905

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female