MAUDE Adverse Event Report: WATERPIK WATERPIK; ORAL IRRIGATION

Model Number	WF-10W010
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Not available.
Event or Problem Description
This spontaneous case was reported by a consumer from the united states of america via other source.The reporter (consumer) reported using waterpik-360 cordless.As per description, "customer complained about 2 units not working, with one overheating and burning a hole through the device.Uses device twice daily and leaves on the charger between uses.Does not use additives and has never cleaned.This is a potential source of ignition." medical history and concomitant medication - unknown.

• Brand Name: WATERPIK
• 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: 24038529
• Report Number: 1712259-2026-00003
• Device Sequence Number: 21085209
• Product Code: EFS
• UDI-Device Identifier: 00073950257176
• UDI-Public: 073950257176
• 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): 01/12/2026

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: WF-10W010
• Device Catalogue Number: NOT AVAIL.
• Device Lot Number: 250115HHJM
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2025
• Initial Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/15/2025
• 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