FDA Adverse Event
Malfunction
Summary report: N
HOLMES
MDR report key: 6186497
·
Received December 19, 2016
Report
- Report Number
- 3003862163-2016-00203
- Event Type
- Malfunction
- Date Received
- December 19, 2016
- Report Date
- January 23, 2017
- Manufacturer
- SUNBEAM PRODUCTS, INC., DBA JARDEN CONSUMER SOLUTI
- Product Code
- KFZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONSUMER HAS NOT RETURNED UNIT.
Additional Manufacturer Narrative · 1
CONSUMER'S FAILURE TO PROPERLY CLEAN/MAINTAIN THE HUMIDIFIER IS A VIOLATION OF THE INSTRUCTIONS AND WARNINGS PROVIDED AND LED TO THE INCIDENT.
Description of Event or Problem · 1
CONSUMER ALLEGES HIS HUMIDIFIER MELTED AT THE BOTTOM AND BURNED HIS HARDWOOD FLOOR. THERE WAS NOT A REPORT OF PERSONAL INJURY WITH THIS INCIDENT.
Description of Event or Problem · 1
CONSUMER ALLEGES HIS HUMIDIFIER MELTED AT THE BOTTOM AND BURNED HIS HARDWOOD FLOOR. THERE WAS NOT A REPORT OF PERSONAL INJURY WITH THIS INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 835825 | HOLMES | HUMIDIFIER | KFZ | SUNBEAM PRODUCTS, INC., DBA JARDEN CONSUMER SOLUTI | HM5305 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |