FDA Adverse Event
Injury
Summary report: N
WATER PIK WATER FLOSSER
MDR report key: 10083051
·
Received May 22, 2020
Report
- Report Number
- 1712259-2020-00003
- Event Type
- Injury
- Date Received
- May 22, 2020
- Date of Event
- May 4, 2020
- Report Date
- May 22, 2020
- Manufacturer
- WATER PIK, INC.
- Product Code
- EFS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 501
Narratives
Description of Event or Problem · 1
CUSTOMER CLAIMS USE OF FLOSSER CHIPPED FRONT TOOTH. CUSTOMER CLAIMS SHE WAS NOT AWARE OF ANY PREEXISTING CONDITIONS THAT COULD HAVE WEAKENED TOOTH. CUSTOMER RETURNED AND REFUNDED PRODUCT VIA SELLER, REFUSED UPGRADE/ALTERNATE PRODUCT. CUSTOMER STATED HER DENTAL PROFESSIONAL WOULD FORWARD STATEMENT PROMPTING WATERPIK TO PAY FOR REPAIR OF DAMAGED TOOTH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 547148 | WATER PIK WATER FLOSSER | ORAL IRRIGATOR | EFS | WATER PIK, INC. | WP560 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |