FDA Adverse Event
Malfunction
Summary report: N
SONICARE
MDR report key: 6840496
·
Received September 1, 2017
Report
- Report Number
- 3026630-2017-00133
- Event Type
- Malfunction
- Date Received
- September 1, 2017
- Date of Event
- August 30, 2017
- Report Date
- August 31, 2017
- Manufacturer
- PHILIPS ORAL HEALTHCARE
- Product Code
- JEQ
- PMA / PMN Number
- EXEMPT
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
CONSUMER STATED RECENTLY PURCHASED TOOTHBRUSH HEADS FOR MY (B)(6) AND THE BRISTLES HAVE CONTINUOUSLY FALLEN OUT WHILE BRUSHING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 618304 | SONICARE | PLAQUE CONTROL BRUSH HEAD | JEQ | PHILIPS ORAL HEALTHCARE | HX9023 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |