FDA Adverse Event
Injury
Summary report: N
HOLMES
MDR report key: 3779388
·
Received April 21, 2014
Report
- Report Number
- 3003862163-2014-00074
- Event Type
- Injury
- Date Received
- April 21, 2014
- Date of Event
- March 2, 2014
- Report Date
- April 21, 2014
- Manufacturer
- SUNBEAM PRODUCTS, INC.
- Product Code
- KFZ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AK, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONSUMER PLACED THE HUMIDIFIER WITHIN REACH OF A CHILD WHICH IS A MISUSE OF THE PRODUCT AND A DIRECT VIOLATION OF THE INSTRUCTIONS AND WARNINGS PROVIDED.
Description of Event or Problem · 1
CONSUMER IS CLAIMING THAT SHE HAD A HUMIDIFIER SET UP IN HER CHILD'S ROOM AND THE CHILD TRIED MOVING THE HUMIDIFIER CAUSING HOT WATER TO SPILL ON HER LEG. SHE IS ALLEGING THE CHILD SUFFERED SECOND DEGREE BURN ON THIGH, ANKLE AND FOOT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 241843 | HOLMES | HUMIDIFIER | KFZ | SUNBEAM PRODUCTS, INC. | HM5082 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |