FDA Adverse Event
Other
Summary report: N
SONICARE
MDR report key: 3592659
·
Received January 8, 2014
Report
- Report Number
- 3026630-2013-00032
- Event Type
- Other
- Date Received
- January 8, 2014
- Date of Event
- December 13, 2013
- Report Date
- December 31, 2013
- Manufacturer
- PHILIPS ORAL HEALTHCARE
- Product Code
- JEQ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ON (B)(4) 2013, A VOICE MAIL WAS LEFT REQUESTING THAT THE CONSUMER CALL US BACK. ON (B)(4) 2013, REQUEST FOR DENTAL INFO IN RELATION TO THIS CLAIMED INCIDENT WAS 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 |
|---|---|---|---|---|---|---|---|
| 14833 | SONICARE | HEALTHYWHITE | JEQ | PHILIPS ORAL HEALTHCARE | HX6711 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |