FDA Adverse Event
Malfunction
Summary report: N
HEATING PAD 0321
MDR report key: 16112983
·
Received January 5, 2023
Report
- Report Number
- MW5114193
- Event Type
- Malfunction
- Date Received
- January 5, 2023
- Report Date
- January 3, 2023
- Manufacturer
- WHELE LLC.
- Product Code
- IRT
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- PATIENT
- Health Professional
- *
Narratives
Description of Event or Problem · 0
PRODUCT RECALL. NOTIFIED BY AMAZON.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 438963 | HEATING PAD 0321 | PAD, HEATING, POWERED | IRT | WHELE LLC. | NA-H21B | 210310 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Female |