FDA Adverse Event
Malfunction
Summary report: N
HOLMES
MDR report key: 3788512
·
Received April 3, 2014
Report
- Report Number
- 3003862163-2014-00063
- Event Type
- Malfunction
- Date Received
- April 3, 2014
- Report Date
- April 3, 2014
- Manufacturer
- SUNBEAM PRODUCTS INC
- 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 WAS SENT TO THE CONSUMER FOR RETURN OF THE PRODUCT. PRODUCT HAS NOT BEEN RETURNED.
Description of Event or Problem · 1
CONSUMER ALLEGES HIS HUMIDIFIER STARTED SMOKING AND STOPPED WORKING. NO INJURIES OR PROPERTY DAMAGES WERE REPORTED WITH THIS INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 201738 | HOLMES | HUMIDIFIER | KFZ | SUNBEAM PRODUCTS INC | HWM6000 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |