BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIGHTY BLISS HEATING PAD

    MDR report key: 16505057 · Received March 7, 2023

    Report

    Report Number
    MW5115556
    Event Type
    Injury
    Date Received
    March 7, 2023
    Date of Event
    February 24, 2023
    Report Date
    March 4, 2023
    Manufacturer
    WHELE LLC
    Product Code
    IRT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    SKIN RASH/HIVES AND IRRITATION THAT I HAD TO GO TO THE HOSPITAL TO GET MEDICATION FOR. I ORIGINALLY THOUGHT IT WAS A MEDICATION REACTION BUT I'M NOW SEEING THIS RECALL AND HAVE BEEN USING THIS HEATING PAD CONSISTENTLY FOR MULTIPLE DAYS AND THIS IS DEFINITELY MORE LIKELY THE CULPRIT AS I HAVE STILL USED IT SINCE BEING AT THE HOSPITAL AND IT HAS NOT GOTTEN BETTER YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140244 MIGHTY BLISS HEATING PAD PAD, HEATING, POWERED IRT WHELE LLC MB-001 (NA-H1121B) 210801

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization MEDICATION FROM HOSPITAL