N
Patient 1
KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING, BUT IT HAS NOT YET BEEN RECEIVED.
MAUDE MDR 8639846
- MDR report key
- 8639846
- Report number
- 1314800-2019-00029
- Event key
- 0
- Event type
- 3
- Date received
- 2019-05-24
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 3
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- SONJA WILKINSON
- Address
- 400 DONALD LYNCH BOULEVARD SUITE 300 MARLBOROUGH MA 01752 US
- Phone
- 508-508-5084
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | VICKS | ELECTRIC STEAM INHALER | KAZ USA, INC., A HELEN OF TROY COMPANY | KFZ | V1200 | 22216 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-05-24 | 0 | 1. O; 2. R |
Event Narratives#
D
Patient 1
A CONSUMER REPORTED THAT SHE RECEIVED SECOND DEGREE BURNS ON FOUR OF HER FINGERS AND RIGHT ARM FROM HOT WATER FROM THE PERSONAL STEAM INHALER. MEDICAL INTERVENTION WAS SOUGHT FOR THEIR INJURIES, AND FOLLOW UP TREATMENT WAS SOUGHT AT A BURN CLINIC. THE INSTRUCTIONS FOR PROPER USE HAVE A CLEAR WARNING THAT STATES "THE APPLIANCE SHOULD ALWAYS BE PLACED ON A FIRM, FLAT WATERPROOF SURFACE", "CAUTION: DO NOT PLACE ON LAP OR LIFT IN YOUR HANDS WHILE IN OPERATION AND IF THE UNIT STILL CONTAINS WATER", AND "NEVER MOVE THE APPLIANCE WHILE IN USE. IT CAN SPILL HOT WATER IF TILTED OR TIPPED OVER CAUSING INJURY." KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING.