FDA Adverse Event Injury Summary report: N

MIGHTY BLISS HEATING PAD

MDR report key: 16530257 · Received March 13, 2023

Report

Report Number
MW5115683
Event Type
Injury
Date Received
March 13, 2023
Date of Event
January 30, 2023
Report Date
March 13, 2023
Manufacturer
WHELE LLC.
Product Code
IRT
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
NY, US
Reporter Occupation
PATIENT
Health Professional
N

Narratives

Description of Event or Problem · 0

PATIENT CALLED TO REPORT AN ADVERSE EVENT INVOLVING A MIGHTY BLISS HEATING PAD SHE PURCHASED IN (B)(6) 2021. PATIENT STATED SHE USED THE HEATING PAD ON HER LEG ON (B)(6) 2023 AND NOTICED IT STARTED TO FEEL VERY HOT. SHE STATED SHE REMOVED THE PAD AND WENT BACK TO SLEEP, AND THAT INITIALLY IT DIDN'T HURT TOO MUCH, BUT THE AREA WAS RED AND WAXY LOOKING. PATIENT STATED THAT ON (B)(6) 2023, SHE NOTICED BLISTERS FORMING IN THE AREA ON HER LEG AND ONE OF THE BLISTERS WAS ABOUT THE SIZE OF A HALF DOLLAR, THERE WERE OTHER SMALLER BLISTERS TOO. SHE STATED IT THEN BEGAN ITCHING AND SHE WENT TO THE DOCTOR AND WAS TOLD THAT HER BURN WAS A THIRD DEGREE BURN THAT WAS INTO THE FAT LAYER. THE BIG BLISTER BURST OPEN AND WAS OOZING. SHE STATED THAT THE MORE IT HEALS THE WORSE THE ITCHING AND PAIN GETS, AND THE BIG BLISTER HAS A VERY THICK SCAB. SHE SAID SHE HAS BEEN REFERRED TO A WOUND SPECIALIST TO MAKE SURE IT HEALS PROPERLY. SHE SAID SHE WAS TOLD IT IS NOT INFECTED, BUT IT IS INFLAMED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
445490 MIGHTY BLISS HEATING PAD PAD, HEATING, POWERED IRT WHELE LLC. NA-H1721B

Patients

Seq Age Sex Outcome Treatment
1 58 YR Female Other