FDA Adverse Event
Injury
Summary report: N
SONICARE
MDR report key: 4490277
·
Received February 3, 2015
Report
- Report Number
- 3026630-2015-00008
- Event Type
- Injury
- Date Received
- February 3, 2015
- Date of Event
- January 13, 2015
- Report Date
- February 2, 2015
- Manufacturer
- PHILIPS ORAL HEALTHCARE, INC.
- Product Code
- JEQ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
CONSUMER IS NOT RESPONDING TO CONTACT ATTEMPTS.
Description of Event or Problem · 1
ON (B)(6) 2015 CUSTOMER CLAIMED THAT MOLD IN HER TOOTHBRUSH IS CAUSING HER TO GET THRUSH. SHE HAS BEEN TREATED FOR THRUSH THREE TIMES BY HER DOCTOR. SHE CLAIMS THEY BELIEVED IT WAS CAUSED BY HER DIABETES UNTIL SHE NOTICED THE MOLD INSIDE HER TOOTHBRUSH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 77625 | SONICARE | ESSENCE | JEQ | PHILIPS ORAL HEALTHCARE, INC. | HX5310 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |