MAUDE Adverse Event Report: WATERPIK WATERPIK; ORAL IRRIGATION

Model Number	WF-05
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As per the reporter (consumer), waterpik flosser-05 was used and noticed a visible spark and an audible popping sound coming from the unit.The cord has visible charring and damage.This report was received via other source from the united states of america on 09-apr-2026.The reporter reported using waterpik flosser-05 via oral route.As per the reporter, "the consumer was using the device when he saw a visible spark and an audible popping sound coming from the unit.The cord has visible charring and damage.Uses once daily on setting 5-6.Does not clean with water/vinegar, occasionally uses mouthwash but dilutes it with water, stored under normal conditions-no stress to power cable".No additional information was available.Medical history and concomitant medications - unknown.
Additional Manufacturer Narrative
Not avail.

• 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: 24944212
• Report Number: 1712259-2026-00007
• Device Sequence Number: 5278423
• Product Code: EFS
• UDI-Device Identifier: 00073950222891
• UDI-Public: 073950222891
• 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: Other Health Care 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: Health Professional
• Device Model Number: WF-05
• Device Catalogue Number: NOT AVAIL.
• Device Lot Number: 200516AJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/16/2020
• 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: Male