FDA Adverse Event
Malfunction
Summary report: N
SONICAR FLEXCARE INTEGRATED SANITIZER
MDR report key: 1517835
·
Received October 22, 2009
Report
- Report Number
- 3026630-2009-00002
- Event Type
- Malfunction
- Date Received
- October 22, 2009
- Date of Event
- September 23, 2009
- Report Date
- October 22, 2009
- Manufacturer
- PHILIPS ORAL HEALTHCARE
- Product Code
- NOB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THE CONSUMER SAW SMOKE COMING OUT OF HIS BATHROOM; IT HAPPENED AROUND ELEVEN IN THE EVENING. IT WAS NOT BEING USED. THE UV LIGHT SANITIZER FAILED, MELTING FROM THE TOP OF THE UNIT. THE UNIT LEFT BLACK MARKINGS IN THE AREA AROUND THE FAILED UNIT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SONICAR FLEXCARE INTEGRATED SANITIZER | UNIT, ULTRAVIOLET SANITATION/STERILIZATION | NOB | PHILIPS ORAL HEALTHCARE | HX6150 | 0749 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR | Required Intervention |