FDA Adverse Event
Injury
Summary report: N
PHILIPS SONICARE
MDR report key: 7220553
·
Received January 25, 2018
Report
- Report Number
- 3026630-2018-00171
- Event Type
- Injury
- Date Received
- January 25, 2018
- Date of Event
- November 10, 2017
- Report Date
- January 18, 2018
- Product Code
- EFS
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
CONSUMER STATED THEY EXPERIENCED CHIPPED TEETH. (B)(6).
Additional Manufacturer Narrative · 1
ADDITIONAL PRODUCTS RETURNED AND ANALYZED; NO MALFUNCTION FOUND: PART NUMBER: DATE CODE: DESCRIPTION: HX801X, 130416-21, AIRFLOSS NOZZLE (NOZZLE #1). HX801X, 160630-22, AIRFLOSS NOZZLE (NOZZLE #2). HX801X, 130410-21, AIRFLOSS NOZZLE (NOZZLE #3). THE ROOT CAUSE OF THE CUSTOMER'S COMPLAINT CANNOT BE DETERMINED.
Description of Event or Problem · 1
CONSUMER STATED THEY EXPERIENECED CHIPPED MOLARS WHEN USING THE AIRFLOSS 1.5.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 64253 | PHILIPS SONICARE | AIRFLOSS 1.5 | EFS | HX8240 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |