FDA Adverse Event
Malfunction
Summary report: N
WATER PIK COMPLETE CARE WATER FLOSSER
MDR report key: 20055783
·
Received August 23, 2024
Report
- Report Number
- 0001712259-2024-00013
- Event Type
- Malfunction
- Date Received
- August 23, 2024
- Date of Event
- July 29, 2024
- Report Date
- August 23, 2024
- 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
CUSTOMER STATES: THE TOOTHBRUSH SLOWED DOWN, THEN HEATED UP, I MANAGED TO THROUGH IT ON THE BALCONY BEFORE THE BATTERY WENT UP IN FLAMES. THE CUSTOMER HAS RETURNED THE UNIT TO BEST BUY. HE STATES THAT HE INHALED THE SMOKE, HAS A BURN ON HIS HAND, AND DAMAGE TO THE BALCONY. I HAVE ATTACHED ALL PICTURES RECEIVED. CUSTOMER STATES HE WILL BE SENDING A VIDEO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1527835 | WATER PIK COMPLETE CARE WATER FLOSSER | ORAL IRRIGATOR | EFS | WATER PIK INC. | WP-861 | 230517AJM |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Other |