FDA Adverse Event
Other
Summary report: N
SONICARE
MDR report key: 3592663
·
Received January 8, 2014
Report
- Report Number
- 3026630-2013-00033
- Event Type
- Other
- Date Received
- January 8, 2014
- Date of Event
- December 17, 2013
- Report Date
- December 31, 2013
- Manufacturer
- PHILIPS ORAL HEALTHCARE
- Product Code
- JEQ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ON (B)(6) 2013, CUSTOMER CLAIMS WHEN USING TOOTHBRUSH THAT THE HANDLE WAS VIBRATING IRREGULARLY AND HIT HIS TWO FRONT WHICH CAUSED THEM TO CHIP. REQUESTED THAT THE UNIT BE RETURNED FOR EVAL. ON (B)(4) 2013, REQUEST FOR DENTAL INFO IN RELATION TO THIS CLAIMED INCIDENT WS SENT TO THE CONSUMER.
Description of Event or Problem · 1
ON (B)(6) 2013, CUSTOMER CLAIMS HE CHIPPED TWO TEETH USING THE UNIT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 14843 | SONICARE | FLEXCARE | JEQ | PHILIPS ORAL HEALTHCARE | HX6950 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |