FDA Adverse Event
Injury
Summary report: N
SONICARE
MDR report key: 4987816
·
Received August 10, 2015
Report
- Report Number
- 3026630-2015-00034
- Event Type
- Injury
- Date Received
- August 10, 2015
- Date of Event
- July 13, 2015
- Report Date
- August 5, 2015
- Manufacturer
- PHILIPS ORAL HEALTHCARE
- Product Code
- JEQ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
OCTOBER 6, 2015, CONSUMER HAS NOT RETURNED THE UNIT FOR EVAL. POHC WILL CONTINUE TO MONITOR FOR TRENDS. NOTED THAT THE CONSUMER WAS NOT FOLLOW BRUSHING INSTRUCTIONS LISTED IN THE DFU GIVEN THAT THE BACK OF THE BRUSH HEAD WAS HITTING THEIR TEETH.
Additional Manufacturer Narrative · 1
ON (B)(6) 2015 CONSUMER STATES THAT HE HAS BEEN PREVIOUSLY DIAGNOSED WITH PERIODONTAL DISEASE. CONSUMER STATES THAT THE TOOTH THAT WAS CHIPPED WAS THE BOTTOM LEFT MOLAR, WHEN THE BACK OF THE BRUSH HEAD HIT HIS TOOTH. CONSUMER AGREED TO RETURN THE UNIT FOR EVALUATION AND PROVIDE DENTAL RECORDS.
Description of Event or Problem · 1
ON (B)(6) 2015 - CUSTOMER CLAIMS THE TOOTHBRUSH CHIPPED HIS TOOTH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 521721 | SONICARE | BLACK DIAMONDCLEAN | JEQ | PHILIPS ORAL HEALTHCARE | HX9350 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |