FDA Adverse Event
Injury
Summary report: N
SONICARE
MDR report key: 4987815
·
Received August 5, 2015
Report
- Report Number
- 3026630-2015-00035
- Event Type
- Injury
- Date Received
- August 5, 2015
- Date of Event
- July 13, 2015
- Report Date
- August 5, 2015
- Manufacturer
- PHILIPS ORAL HEALTHCARE, INC.
- Product Code
- JEQ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
OCTOBER 6, 2015, CUSTOMER HAS NOT RETURNED THE DEVICE FOR EVAL. POHC WILL CONTINUE TO MONITOR FOR TRENDS.
Additional Manufacturer Narrative · 1
ON (B)(6) 2015 CONSUMER STATED THAT THEY USED THE BRUSH 2X A DAY FOR ALMOST 2 WEEKS. CONSUMER STATED THAT THEY HAD RECENTLY RECEIVED A FILLING ON THE MOLAR. CONSUMER STATES THAT THEY DON'T KNOW EXACTLY HOW IT HAPPENED, BUT THEY FEEL THE BRUSH WAS ENTIRELY TOO AGGRESSIVE FOR THEM. CONSUMER STATES THAT THEY NOTICED THE CHIP AS SOON AS THEY BIT DOWN ON THEIR TEETH. CONSUMER HAS YET TO RECEIVE MEDICAL ATTENTION. CONSUMER AGREED TO RETURN THE UNIT FOR EVALUATION.
Description of Event or Problem · 1
ON (B)(6) 2015, CUSTOMER CLAIMS THE TOOTHBRUSH CHIPPED HIS TOOTH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 515851 | SONICARE | 2-SERIES | JEQ | PHILIPS ORAL HEALTHCARE, INC. | HX6210 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |