FDA Adverse Event
Other
Summary report: N
SONICARE
MDR report key: 2872364
·
Received December 5, 2012
Report
- Report Number
- 3026630-2012-00020
- Event Type
- Other
- Date Received
- December 5, 2012
- Date of Event
- November 6, 2012
- Report Date
- December 5, 2012
- Manufacturer
- PHILIPS ORAL HEALTHCARE
- Product Code
- JEQ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ON (B)(6) 2012, CONSUMER STATED THAT HE IS HAVING A CAP PUT ON HIS DAMAGED TOOTH. CONSUMER STATES THAT THE TOOTH HAD PREVIOUS WORK DONE ON IT, A FILLING, HOWEVER, WOULD NOT STATE HOW OLD HIS FILLING WAS. ON (B)(4) 2012, WILL FILE A FOLLOW UP WHEN FAILURE ANALYSIS IS COMPLETED.
Description of Event or Problem · 1
ON (B)(6) 2012, CONSUMER STATED THAT THEY CHIPPED THEIR TOOTH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SONICARE | HEALTHYWHITE | JEQ | PHILIPS ORAL HEALTHCARE | HX6711 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |