FDA Adverse Event
Injury
Summary report: N
WATER PIK CORDLESS WATER FLOSSER
MDR report key: 12898885
·
Received November 30, 2021
Report
- Report Number
- 0001712259-2021-00007
- Event Type
- Injury
- Date Received
- November 30, 2021
- Report Date
- November 30, 2021
- Manufacturer
- WATER PIK, INC.
- Product Code
- EFS
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- 501
Narratives
Description of Event or Problem · 0
THE CUSTOMER SENT IN THEIR WP360. THE SERIAL NUMBER IS (B)(4). SHE DID NOT SEND OVER HER ANYWAY OF CONTACTING HER. IT APPEARS AS THOUGH SHE HAD AN ISSUE WITH A TOOTH AND WENT TO VISIT A DENTAL PROFESSIONAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1799722 | WATER PIK CORDLESS WATER FLOSSER | ORAL IRRIGATOR | EFS | WATER PIK, INC. | WP-360 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female |