FDA Adverse Event
Malfunction
Summary report: N
WATERPIK WATER FLOSSER
MDR report key: 5015922
·
Received August 19, 2015
Report
- Report Number
- 0001712259-2015-00004
- Event Type
- Malfunction
- Date Received
- August 19, 2015
- Date of Event
- July 17, 2015
- Report Date
- August 19, 2015
- Manufacturer
- WATER PIK, INC.
- Product Code
- EFS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
UNIT IN QUESTION HAS NOT YET BEEN RETURNED FOR TESTING AND EVALUATION. DEVICE IN QUESTION HAS NOT BEEN RECEIVED.
Description of Event or Problem · 1
PER THE CUSTOMER....CLAIMS THE POWER HANDLE CAUGHT FIRE IMMEDIATELY UPON PLUGGING IN CHARGER. UNIT WAS RETURNED TO RETAILER AND SUBSEQUENTLY DISCARDED, CANNOT BE RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 548337 | WATERPIK WATER FLOSSER | ORAL IRRIGATOR | EFS | WATER PIK, INC. | WP-450 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR |