MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional report with the FDA on 2019-01-25 for VICKS V745A manufactured by Kaz Usa, Inc., A Helen Of Troy Company.
[134099177]
A consumer called and stated that he received second degree burns on his leg from the hot water that was leaking out of their humidifier while he was sleeping. The consumer stated that he is a doctor, and that he was treating the injury himself. The instructions for proper use have very clear warnings that states, "the appliance should always be placed on a firm, flat, waterproof surface at least four feet away from bedside, twelve inches from the wall and out of reach of patient, children and pets. " it also states, "be sure the removable water tray and cooling chamber are in place and the cooling chamber interlock is engaged. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1314800-2019-00011 |
| MDR Report Key | 8277856 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2019-01-25 |
| Date of Report | 2019-01-25 |
| Date of Event | 2018-12-21 |
| Device Manufacturer Date | 2017-10-16 |
| Date Added to Maude | 2019-01-25 |
| 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 | 2019-01-25 |
| Returned To Mfg | 2019-01-15 |
| Model Number | V745A |
| Lot Number | 28917KUO |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-01-25 |