FDA Adverse Event
Malfunction
Summary report: N
WATER PIK SIDEKICK WATER FLOSSER
MDR report key: 17818513
·
Received September 26, 2023
Report
- Report Number
- 0001712259-2023-00019
- Event Type
- Malfunction
- Date Received
- September 26, 2023
- Date of Event
- August 30, 2023
- Report Date
- September 26, 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
CUSTOMER CHATTED IN STATING THAT TRANSFORMER FOR HER UNIT MELTED AND SHE WAS SEEKING A REPLACEMENT TO THIS PART. PHOTOS HAVE BEEN PROVIDED HER THE AGENT REQUEST (ATTACHED). AWAITING RESPONSE TO WHEN/WHERE PURCHASED, WHEN/HOW ISSUE OCCURRED, ADDITIVES, CLEANING, TRANSFORMER STORAGE AND RECEIPT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 985240 | WATER PIK SIDEKICK WATER FLOSSER | FLOSSER | EFS | WATER PIK INC. | WF-04 | 210517AP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Other |