FDA Adverse Event
Malfunction
Summary report: N
WATER PIK CORDLESS SLIDE PROFESSIONAL WATER FLOSSER
MDR report key: 17515362
·
Received August 11, 2023
Report
- Report Number
- 0001712259-2023-00012
- Event Type
- Malfunction
- Date Received
- August 11, 2023
- Date of Event
- August 4, 2023
- Report Date
- August 11, 2023
- Manufacturer
- WATER PIK INC.
- Product Code
- EFS
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- 501
Narratives
Description of Event or Problem · 0
UNIT BURNT AT UNIT CHARGING PORT AND GOT VERY HOT WHEN IT WAS BEING CHARGED FOR THE FIRST TIME. DETERMINED THAT THE UNIT EXPERIENCED THE BURNING UPON INITIAL CHARGE AND WAS CHALLENGING TO SEPARATE CORD FROM UNIT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 763559 | WATER PIK CORDLESS SLIDE PROFESSIONAL WATER FLOSSER | ORAL IRRIGATOR | EFS | WATER PIK INC. | WF-17 | 230207HAPR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Other |