MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-10 for SUNBEAM 1361-705 manufactured by Sunbeam Products, Inc., Dba Jarden Consumer Soluti.
[56917456]
Product instructions and warnings clearly state to keep children away from this product. Consumer did not heed the warnings and instructions. Consumer has not returned the product.
Patient Sequence No: 1, Text Type: N, H10
[56917457]
Consumer is alleging that her son put his hand over the steam output and received a burn.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003862163-2016-00164 |
| MDR Report Key | 6015472 |
| Date Received | 2016-10-10 |
| Date of Report | 2016-10-10 |
| Date of Event | 2016-09-13 |
| Date Added to Maude | 2016-10-10 |
| 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 | TRACIE JONES |
| Manufacturer Street | P.O. BOX 2931 |
| Manufacturer City | WICHITA KS 67201 |
| Manufacturer Country | US |
| Manufacturer Postal | 67201 |
| Manufacturer Phone | 3162197325 |
| Manufacturer G1 | DONGGUAN HUIXAN ELECTRICAL PRODUCTS CO. |
| Manufacturer Street | NO. 9112, HUNG YEH 8TH ROAD |
| Manufacturer City | TANGXIA TOWN, DONGGUAN |
| Manufacturer Country | CH |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SUNBEAM |
| Generic Name | VAPORIZER |
| Product Code | CAD |
| Date Received | 2016-10-10 |
| Model Number | 1361-705 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SUNBEAM PRODUCTS, INC., DBA JARDEN CONSUMER SOLUTI |
| Manufacturer Address | 2381 EXECUTIVE CENTER DR. BOCA RATON FL 33431 US 33431 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-10-10 |