FDA Adverse Event
Injury
Summary report: N
WATERPIK WATER FLOSSER
MDR report key: 5085106
·
Received September 17, 2015
Report
- Report Number
- 0001712259-2015-00005
- Event Type
- Injury
- Date Received
- September 17, 2015
- Date of Event
- August 20, 2015
- Report Date
- September 16, 2015
- Manufacturer
- WATER PIK, INC.
- Product Code
- EFS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TESTING OF RETURNED UNIT SHOWED PRESSURES IN NORMAL RANGE. PRODUCT OPERATED NORMALLY.
Description of Event or Problem · 1
PER THE CUSTOMER....CLAIMS USE AT MAXIMUM PRESSURE CAUSED DISCOLORATION AND PAINFUL INFLAMMATION OF THE GUMS. CUSTOMER ALLEGES USE OF WATER FLOSSER PUSHED BACTERIA INTO GUMLINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 615671 | WATERPIK WATER FLOSSER | ORAL IRRIGATOR | EFS | WATER PIK, INC. | WP-100 | 140402 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Other |