MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-13 for CVS HEALTH GIH120 manufactured by Kaz Usa, Inc., A Helen Of Troy Company.
[183374121]
Kaz usa, inc. Has requested that the product be returned to our company for testing, but it has not yet been received.
Patient Sequence No: 1, Text Type: N, H10
[183374122]
A consumer reported that she received second degree burns on her thigh from hot water that spilled out of the personal steam inhaler. It is unknown whether medical intervention was sought for their injuries. Incidents of this nature are most likely to occur if the unit is being moved or lifted during use. 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 or burns". Kaz usa, inc. Has requested that the product be returned to our company for testing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1314800-2020-00014 |
| MDR Report Key | 9831407 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-13 |
| Date of Report | 2020-03-13 |
| Date Mfgr Received | 2020-02-26 |
| Device Manufacturer Date | 2019-08-23 |
| Date Added to Maude | 2020-03-13 |
| 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 |
| Manufacturer Country | US |
| Manufacturer Phone | 4907236 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CVS HEALTH |
| Generic Name | STEAM INHALER |
| Product Code | KFZ |
| Date Received | 2020-03-13 |
| Model Number | GIH120 |
| Lot Number | 23519MGH |
| 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 | 400 DONALD LYNCH BOULEVARD MARLBOROUGH, MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-13 |