MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2019-09-06 for VICKS V750D1 manufactured by Kaz Usa, Inc., A Helen Of Troy Company.
[156764648]
Kaz usa, inc. Would like to retrieve this unit for testing, but we were not provided any consumer contact information.
Patient Sequence No: 1, Text Type: N, H10
[156764649]
We received a complaint from the fda's medwatch program, report number mw5084694. A consumer reported that their humidifier was unplugged and six hours later the unit was smoking and still steaming. No adverse event was reported. Kaz usa, inc. Would like to retrieve this unit for testing, but we were not provided any consumer contact information. The root cause for this specific complaint could not be determined since the product was not available for investigation. There are no components or parts on the device that can overheat when unplugged. We therefore believe that the mentioned failure is an isolated, abnormal event that is extremely remote and that we would not anticipate to occur.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1314800-2019-00044 |
| MDR Report Key | 8969833 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2019-09-06 |
| Date of Report | 2019-09-06 |
| Date of Event | 2019-01-15 |
| Date Mfgr Received | 2019-08-12 |
| Date Added to Maude | 2019-09-06 |
| 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 | WARM MIST HUMIDIFIER |
| Product Code | KFZ |
| Date Received | 2019-09-06 |
| Model Number | V750D1 |
| 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. Other | 2019-09-06 |