MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-08 for VICKS WARM STEAM VAPORIZER manufactured by Kaz Usa, Inc., A Helen Of Troy Company.
[174672871]
Product was new out of the box. Product was used as intended - vaporizing water for health benefits. Product dimmed lights several times then tripped breaker. Returned product. Repeated use, same issue. Numerous reports on online reviews of same issue over several years. Document no: (b)(4). Report no: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092119 |
| MDR Report Key | 9569418 |
| Date Received | 2020-01-08 |
| Date of Report | 2020-01-08 |
| Date of Event | 2019-12-15 |
| Date Added to Maude | 2020-01-09 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | UNKNOWN |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VICKS WARM STEAM VAPORIZER |
| Generic Name | HUMIDIFIER, NON-DIREC PATIENT INTERFACE (HOME - USE) |
| Product Code | KFZ |
| Date Received | 2020-01-08 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KAZ USA, INC., A HELEN OF TROY COMPANY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-08 |