MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-04-04 for VICKS V150SG manufactured by Kaz Usa, Inc., A Helen Of Troy Company.
[141027905]
A consumer called and stated she received first and second degree burns on her foot from the hot steam that was coming out of their vaporizer. The woman received medical treatment at an urgent care facility, and follow up care was required due to an infection. The instructions for proper use have very clear warnings that state, "it is a device that produces hot steam and could cause severe burns and injuries if they do not stay away from it", and "vaporizer should always be placed on a firm, flat, waterproof surface at least four feet away from bedside and out of reach of patient and children. " kaz usa, inc. Has requested that the product be returned for testing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1314800-2019-00020 |
| MDR Report Key | 8484218 |
| Report Source | CONSUMER |
| Date Received | 2019-04-04 |
| Date of Report | 2019-04-04 |
| Date of Event | 2019-03-02 |
| Date Mfgr Received | 2019-03-05 |
| Device Manufacturer Date | 2018-09-27 |
| Date Added to Maude | 2019-04-04 |
| 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 | 2019-04-04 |
| Returned To Mfg | 2019-03-25 |
| Model Number | V150SG |
| Lot Number | 27018KTC |
| Operator | LAY USER/PATIENT |
| 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 | 2019-04-04 |