MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-03-29 for VICKS V150SGNL manufactured by Kaz Usa, Inc., A Helen Of Troy Company.
[140305778]
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
[140305779]
A consumer reported that she received 2nd degree burns from boiling water while filling her warm steam vaporizer. She stated that she was treated at a hospital for her injuries. The instructions for proper use have clear warnings which states that, "it is a device that produces hot steam and could cause severe burns and injuries", and "do not remove the appliance head during operation or within 20-30 minutes after it is unplugged. " kaz usa, inc. Has requested that the product be returned for testing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1314800-2019-00019 |
| MDR Report Key | 8464255 |
| Report Source | CONSUMER |
| Date Received | 2019-03-29 |
| Date of Report | 2019-06-26 |
| Date of Event | 2018-09-03 |
| Date Mfgr Received | 2019-03-01 |
| Device Manufacturer Date | 2017-08-21 |
| Date Added to Maude | 2019-03-29 |
| 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 STEAM VAPORIZER |
| Product Code | KFZ |
| Date Received | 2019-03-29 |
| Model Number | V150SGNL |
| Lot Number | 23317 |
| 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 MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2019-03-29 |