MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-03-13 for VICKS VWM845 manufactured by Kaz Usa, Inc., A Helen Of Troy Company.
[138692418]
Kaz usa, inc. Has requested that the product be returned for testing, but the item has not yet been received.
Patient Sequence No: 1, Text Type: N, H10
[138692419]
A consumer called and stated that their infant child burns from the hot water that was spilled out of their warm mist humidifier. It was stated that the child pulled on the product's electrical cord which pulled the unit off of their night stand pulled it down on himself, and that is when the injuries occurred. The child received medical treatment at a hospital for a second degree burns on his back, shoulder, chest, and face, and he also required follow up care for his injuries. The instructions for proper use have very clear warnings that state, "warning : keep out of reach of children. This product produces hot steam and should be placed in an area not accessible to children or pets, with the power cord out of reach". Kaz usa, inc. Has requested that the product be returned for testing, but it has not yet been received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1314800-2019-00016 |
| MDR Report Key | 8417224 |
| Report Source | CONSUMER |
| Date Received | 2019-03-13 |
| Date of Report | 2019-03-13 |
| Date of Event | 2019-01-25 |
| Date Mfgr Received | 2019-02-11 |
| Device Manufacturer Date | 2018-06-11 |
| Date Added to Maude | 2019-03-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SONJA WILKINSON |
| Manufacturer Street | 400 DONALD LYNCH BOULEVARD SUITE 300 |
| Manufacturer City | MARLBOROUGH 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5084907236 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VICKS |
| Generic Name | WARM MIST HUMIDIFIER |
| Product Code | KFZ |
| Date Received | 2019-03-13 |
| Model Number | VWM845 |
| Lot Number | 16218 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KAZ USA, INC., A HELEN OF TROY COMPANY |
| Manufacturer Address | MARLBOROUGH 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2019-03-13 |