MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-14 for VICKS V1200 manufactured by Kaz Usa, Inc., A Helen Of Troy Company.
[189067740]
(b)(4) has requested that the product be returned to our company for testing, but this complaint came directly from an online retailer, and no consumer information was provided.
Patient Sequence No: 1, Text Type: N, H10
[189067741]
A consumer reported to (b)(6) that his wife received second degree burns from hot water that spilled out of a the personal steam inhaler during use. Medical intervention was sought for their injuries, and it was stated that surgery was needed. They also stated that the the vent control and face mask is very hard to turn and adjust, and that the water spills easily. 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. " (b)(4). Has requested that the product be returned to our company for testing, but this complaint came directly from an online retailer, and no consumer information was given.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1314800-2020-00006 |
| MDR Report Key | 9586785 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-01-14 |
| Date of Report | 2020-01-14 |
| Date Mfgr Received | 2019-12-18 |
| Date Added to Maude | 2020-01-14 |
| 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 MA 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 | ELECTRIC STEAM INHALER |
| Product Code | KFZ |
| Date Received | 2020-01-14 |
| Model Number | V1200 |
| Lot Number | UNKNOWN |
| 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. Hospitalization; 2. Other; 3. Required No Informationntervention | 2020-01-14 |