FDA Adverse Event
Other
Summary report: N
SONICARE
MDR report key: 3592687
·
Received January 8, 2014
Report
- Report Number
- 3026630-2013-00036
- Event Type
- Other
- Date Received
- January 8, 2014
- Date of Event
- December 27, 2013
- Report Date
- December 31, 2013
- Manufacturer
- PHILIPS ORAL HEALTHCARE
- Product Code
- JEQ
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ON (B)(6) 2013, CONSUMER STATES THAT THEY PURCHASED THE UNIT ABOUT A MONTH AGO. ON (B)(6)2 013, SHE WAS BRUSHING HER TEETH AND THE ENTIRE BRUSH HEAD POPPED OFF. IN THE COMMOTION THE METAL STEM OF THE UNIT SCRATCHED THE SIDE OF HER FACE ON HER CHEEK AREA BREAKING THE SKIN, BUT DID NOT BLEED. REQUESTED THAT THE UNIT BE RETURNED FOR EVAL.
Description of Event or Problem · 1
ON (B)(6) 2013, CUSTOMER CLAIMS SHE SCRAPED HERSELF ON THE METAL PRONG ON THE TOOTHBRUSH AND IT ALMOST POKED HER IN THE EYE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 14793 | SONICARE | FLEXCARE PLATINUM | JEQ | PHILIPS ORAL HEALTHCARE | HX9140 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |