MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2019-05-16 for SUNBEAM 1388-800 manufactured by Sunbeam Products, Inc..
[145256563]
There is an instruction that states, "do not touch unit or steam vapor during use. Steam is hot and burns can occur. " and consumer failed to perform that instruction.
Patient Sequence No: 1, Text Type: N, H10
[145256564]
The consumer filed an incident report with the fda under reference number mw5086366 alleging that a humidifier/vaporizer caused a serious injury to the lower part of their arm. There was not a report of property damage with this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010341502-2019-00035 |
| MDR Report Key | 8615844 |
| Report Source | OTHER |
| Date Received | 2019-05-16 |
| Date of Report | 2019-05-16 |
| Date of Event | 2019-04-03 |
| Date Added to Maude | 2019-05-16 |
| 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 | MICHAEL MILES |
| Manufacturer Street | 303 NELSON AVE. |
| Manufacturer City | NEOSHO MO 64850 |
| Manufacturer Country | US |
| Manufacturer Postal | 64850 |
| Manufacturer Phone | 4174557441 |
| Manufacturer G1 | CHUZHOU DONLIM ELECTRICAL APPLIANCES CO.,LTD. |
| Manufacturer Street | NO.1777 YANGZI EAST ROAD |
| Manufacturer City | CHUZHOU, 239000 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 239000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUNBEAM |
| Generic Name | VAPORIZER |
| Product Code | KFZ |
| Date Received | 2019-05-16 |
| Model Number | 1388-800 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SUNBEAM PRODUCTS, INC. |
| Manufacturer Address | 2381 EXECUTIVE CENTER DR. BOCA RATON FL 33431 US 33431 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-05-16 |