FDA Adverse Event
Other
Summary report: N
VICKS
MDR report key: 4170592
·
Received September 24, 2014
Report
- Report Number
- 1314800-2014-00070
- Event Type
- Other
- Date Received
- September 24, 2014
- Date of Event
- September 12, 2014
- Report Date
- September 22, 2014
- Manufacturer
- KAZ, INC.
- Product Code
- KFZ
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
THE CONSUMER CALLED TO REPORT THAT SHE KNOCKED THE UNIT OVER, AND RECEIVED SECOND DEGREE BURNS ON HER FOOT FROM THE HOT WATER THAT SPILLED OUT OF THE PERSONAL STEAM INHALER. THE PROPER USE INSTRUCTIONS STATE TO ONLY USE THE UNIT ON A FIRM LEVEL SURFACE TO AVOID SPILLING THE WATER. MEDICAL INTERVENTION WAS REQUIRED FOR THE INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 595996 | VICKS | HUMIDIFIER | KFZ | KAZ, INC. | V1200 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |