FDA Adverse Event
Malfunction
Summary report: N
HOLMES
MDR report key: 3220641
·
Received June 25, 2013
Report
- Report Number
- 3003862163-2013-00094
- Event Type
- Malfunction
- Date Received
- June 25, 2013
- Report Date
- June 25, 2013
- Manufacturer
- SUNBEAM PRODUCTS, INC., DBA JARDEN CONSUMER SOLUTIONS
- Product Code
- KFZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONSUMER WAS SENT A PREPAID LABEL TO RETURN THE PRODUCT FOR EVALUATION, BUT THE CONSUMER HAS NOT RETURNED THE PRODUCT.
Description of Event or Problem · 1
CONSUMER ALLEGES A FLAME OCCURRED INSIDE THE HUMIDIFIER THEN EXTINGUISHED ITSELF. NO INJURIES OR PROPERTY DAMAGES WERE REPORTED WITH THIS INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 288582 | HOLMES | HUMIDIFIER | KFZ | SUNBEAM PRODUCTS, INC., DBA JARDEN CONSUMER SOLUTIONS | HM5250 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |