FDA Adverse Event
Malfunction
Summary report: N
HOLMES
MDR report key: 6102452
·
Received November 15, 2016
Report
- Report Number
- 3003862163-2016-00176
- Event Type
- Malfunction
- Date Received
- November 15, 2016
- Report Date
- February 8, 2017
- Manufacturer
- SUNBEAM PRODUCTS, INC., DBA JARDEN CONSUMER SOLUTI
- Product Code
- KFZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
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.
Additional Manufacturer Narrative · 1
CONSUMER HAS NOT RETURNED THE PRODUCT.
Description of Event or Problem · 1
CONSUMER IS ALLEGING THAT HER HUMIDIFIER CAUGHT ON FIRE. THERE WAS NOT A REPORT OF INJURY WITH THIS INCIDENT.
Description of Event or Problem · 1
CONSUMER IS ALLEGING THAT HER HUMIDIFIER CAUGHT ON FIRE. THERE WAS NOT A REPORT OF INJURY WITH THIS INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 754814 | HOLMES | HUMIFIER | KFZ | SUNBEAM PRODUCTS, INC., DBA JARDEN CONSUMER SOLUTI | HM5082 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |