FDA Adverse Event
Injury
Summary report: N
MYPURMIST
MDR report key: 18374990
·
Received December 20, 2023
Report
- Report Number
- MW5149446
- Event Type
- Injury
- Date Received
- December 20, 2023
- Date of Event
- December 17, 2023
- Report Date
- December 18, 2023
- Manufacturer
- VAPORE, LLC.
- Product Code
- KFZ
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- FL, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
PRODUCT FAN STOPPED WORKING, ALLOWING FOR ACCUMULATION OF STEAM ONTO PATIENT'S FACE, RESULTING IN STEAM BURNS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 297413 | MYPURMIST | HUMIDIFIER, NON-DIRECT PATIENT INTERFACE (HOME-USE) | KFZ | VAPORE, LLC. | OSS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 17 YR | Female | Other |