FDA Adverse Event
Injury
Summary report: N
WATER PIK EVOLUTION AND NANO WATER FLOSSER
MDR report key: 15221503
·
Received August 12, 2022
Report
- Report Number
- 0001712259-2022-00006
- Event Type
- Injury
- Date Received
- August 12, 2022
- Date of Event
- July 14, 2022
- Report Date
- August 12, 2022
- 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
CUST CLAIMS US OF SF-01 UNIT CAUSED DAMAGE TO FILLING THAT THE UNIT LOOSENED THE FILLING AND IT "FELL OUT". THEY HAVE NOT SOUGHT MEDICAL ATTENTION YET. HAVE REACHED OUT TO CUSTOMER REQUESTING ANY FURTHER INFORMATION FROM THEM AND HAVE NOT HEARD BACK. REFUND HAS BEEN INITIATED, HAS NOT PROCESSED YET.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1222870 | WATER PIK EVOLUTION AND NANO WATER FLOSSER | ORAL IRRIGATOR | EFS | WATER PIK, INC. | SF-01 | 200804AP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Other |