MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-06 for VICK'S WARM STEAM VAPORIZER HUMIDIFIER WITH NIGHTLIGHT 1.5 GALLONS manufactured by Helen Of Troy Health & Home/ Kaz.
[138100631]
We purchased this humidifier for our bedroom and had used it for 5 consecutive days. It was sitting on top of a dresser and was refilled about 30-40 minutes prior to the incident. My dog yelped and ran under the bed. I noticed his bed was soaked with water despite being about 2 feet away from where the humidifier sat. I grabbed the dog and his back was covered in boiling water. I immediately took him to the sink and ran cold water over his back for several minutes. The burn covered his back and left side. I was unable to afford to take him to the vet so i treated him at home to the best of my ability. The burns are severe and he is still losing hair and skin a month later. I have 2 small children that could have been burned by this unit and it should not be on the market. Purchase date: (b)(6) 2018. Retailer: (b)(6). I reached out to the manufacturer via email and received or form letter in return. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5084693 |
| MDR Report Key | 8396373 |
| Date Received | 2019-03-06 |
| Date of Report | 2019-02-13 |
| Date of Event | 2019-01-12 |
| Date Added to Maude | 2019-03-06 |
| 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 | PATIENT FAMILY MEMBER OR FRIEND |
| 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 | 0 |
| Brand Name | VICK'S WARM STEAM VAPORIZER HUMIDIFIER WITH NIGHTLIGHT 1.5 GALLONS |
| Generic Name | HUMIDIFIER, NON-DIRECT PATIENT INTERFACE |
| Product Code | KFZ |
| Date Received | 2019-03-06 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HELEN OF TROY HEALTH & HOME/ KAZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-06 |