FDA Adverse Event
Malfunction
Summary report: N
BIONAIRE
MDR report key: 3881231
·
Received February 13, 2014
Report
- Report Number
- 3003862163-2014-00030
- Event Type
- Malfunction
- Date Received
- February 13, 2014
- Report Date
- February 13, 2014
- Manufacturer
- SUNBEAM PRODUCTS, INC. DBA JARDEN CONSUMER SOLUTIONS
- Product Code
- KFZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A PREPAID LABEL HAS BEEN SENT TO THE CONSUMER FOR RETURN OF THE PRODUCT. CONSUMER HAS NOT RETURNED THE PRODUCT.
Description of Event or Problem · 1
CONSUMER CLAIMS HER HUMIDIFIER CAUGHT ON FIRE. THERE WAS NO REPORTS OF INJURY OR PROPERTY DAMAGE WITH THIS INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 95490 | BIONAIRE | HUMIDIFIER | KFZ | SUNBEAM PRODUCTS, INC. DBA JARDEN CONSUMER SOLUTIONS | CM1 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |