FDA Adverse Event
Injury
Summary report: N
MIGHTYBLISS HEATING PAD
MDR report key: 16573691
·
Received March 17, 2023
Report
- Report Number
- MW5115822
- Event Type
- Injury
- Date Received
- March 17, 2023
- Date of Event
- November 3, 2022
- Report Date
- March 14, 2023
- Manufacturer
- WHELE, LLC
- Product Code
- IRT
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CA, US
- Reporter Occupation
- PATIENT
- Health Professional
- *
Narratives
Description of Event or Problem · 0
I HAD DRAPED HEATING PAD OVER RIGHT SHOULDER AND ARM. THE HEATING PAD GOT EXTREMELY HOT ON MEDIUM HEAT. I TOOK OFF AND NEAR CROOK OF RIGHT ARM I HAD BURN AND SKIN WAS RAW, PLUS SKIN PUSHED BACK. I COULD NOT EVEN IMAGINE HOW THAT HAPPENED WITH HEATING PAD BUT IT DID. MY DAUGHTER HELPED ME CLEAN AND BANDAGE THE AREA FEW DAYS. IT STARTED HEALING WITH USING MEDIHONEY PRODUCT THAT SOME HOSPITAL USE FOR WOUND CARE. THEN I KNEW SOMETHING WAS NOT RIGHT WITH THIS HEATING PAD. IT BURNT MY ARM. STOPPED USING HEATING PAD. LOT NO. 210302, MODEL: NA H21B INTERNET 5005390 HEATING PAD 0321, PURCHASED (B)(6) 2021. I DO HAVE PICTURE OF MIGHTBLISS HEATING PAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 825149 | MIGHTYBLISS HEATING PAD | PAD, HEATING, POWERED | IRT | WHELE, LLC | NA-H21B | 210302 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Female | Other |