FDA Adverse Event
Other
Summary report: N
SONICARE
MDR report key: 2879417
·
Received November 14, 2012
Report
- Report Number
- 3026630-2012-00017
- Event Type
- Other
- Date Received
- November 14, 2012
- Date of Event
- October 11, 2012
- Report Date
- November 10, 2012
- Manufacturer
- PHILIPS ORAL HEALTHCARE, INC.
- Product Code
- JEQ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ON (B)(6) 2012, AN EMAIL WAS SENT TO THE CONSUMER REQUESTING A CALL BACK. ON (B)(6) 2012, A VOICEMAIL WAS LEFT FOR THE CONSUMER REQUESTING A CALL BACK. ON (B)(6) 2012, HAVE NOT RECEIVED A CALL BACK FROM THE CONSUMER. HAVE NOT RECEIVED THE UNIT, WILL FILE A FOLLOW UP.
Description of Event or Problem · 1
ON (B)(6) 2012, CONSUMER STATED THAT AFTER THREE WEEKS OF USE SHE BELIEVES THAT THE ENAMEL ON HER TOOTH BEGAN CHIPPING OFF. CONSUMER STATES THAT THERE WAS ONE CHIP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SONICARE | HEALTHYWHITE | JEQ | PHILIPS ORAL HEALTHCARE, INC. | HX6732 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |