FDA Adverse Event
Injury
Summary report: N
SONICARE
MDR report key: 3835839
·
Received May 12, 2014
Report
- Report Number
- 3026630-2014-00014
- Event Type
- Injury
- Date Received
- May 12, 2014
- Date of Event
- April 21, 2014
- Report Date
- May 12, 2014
- Manufacturer
- PHILIPS ORAL HEALTHCARE
- Product Code
- JEQ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(6), 2014 CONSUMER STATED THAT THEY WOULD PROVIDE MORE INFORMATION AFTER THEIR DENTAL APPOINTMENT.
Description of Event or Problem · 1
(B)(6), 2014 CUSTOMER CLAIMS THAT THEY HAVE A FEW CHIPPED TEETH AND ARE WONDERING IF THEY WERE CAUSED BY THE TOOTHBRUSH; CLAIMS THEY ARE SCARED TO USE THE UNIT NOW.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 283407 | SONICARE | HEALTHYWHITE JEQ | JEQ | PHILIPS ORAL HEALTHCARE | HX6711 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |