MAUDE Adverse Event Report: WATERPIK SF-03 SONIC FUSION; ORAL IRRIGATION

Model Number	SF-03W010-1
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
As per the reporter (consumer), sf-03 sonic fusion (waterpik sonic-fusion 2.0) was used and reported that they came home to a burning smell and found the outlet and plug had burned significantly and the device was plugged in all the time.This report was received via other source from the united states of america on 26-mar-2026.As per case description, "thermal event with property damage.Purchased on (b)(6) 2022.Consumer came home to a burning smell and found the outlet and plug had burned significantly.Firefighters were called to check the house and determined that the machine caused the issue.Uses 2x daily.No additive use and has never cleaned.Water is stored in between uses, and device is plugged in all the time." no additional information was available.
Additional Manufacturer Narrative
Not avail.

• Brand Name: SF-03 SONIC FUSION
• Common Device Name: ORAL IRRIGATION
• Manufacturer (Section D): WATERPIK; 1730 e. prospect rd; fort collins CO 80553 0001
• Manufacturer (Section G): WATERPIK; 1730 e. prospect rd; fort collins CO 80553 0001
• Manufacturer Contact: eric rodriguez ; 1730 e. prospect rd; fort collins, CO 80553-0001 ; 9702217038
• MDR Report Key: 24943983
• Report Number: 1712259-2026-00006
• Device Sequence Number: 5278417
• Product Code: EFS
• UDI-Device Identifier: 00073950289764
• UDI-Public: 073950289764
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/21/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: SF-03W010-1
• Device Catalogue Number: NOT AVAIL.
• Device Lot Number: 210422AP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/22/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown