MAUDE Adverse Event Report: WATERPIK WATERPIK; ORAL IRRIGATION

Model Number	WP-100
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Not avail.
Event or Problem Description
As per the reporter (consumer), the waterpik-100 ultra was used and reported that the unit sparked at the cord and base then smoke came out.This report was received via other source from canada on (b)(6) 2026.The consumer (male) reported using the waterpik-100 ultra.As per consumer, "owned since (b)(6) 2024.Unit sparked at the cord and base, then smoke came out.No damage to persons or property besides a burn in the consumer's shirt.Used daily." the consumer further reported "burns on the countertop" and stated, "while using the device, a large spark appeared, followed by a loud popping noise and the power in my bathroom immediately shut off.After unplugging the unit and resetting the breaker, i noticed two black burn marks on my sink as well as on the device itself.No additives and has not been cleaned." the consumer stores the unit by wrapping the cord and states that they are wrapping and unwrapping for each use.During use, the unit shut off, and they tried to power it back on with the power button.They unplugged and plugged back in, then they fiddled with the cord where it attaches to the unit and the unit sparked.They have thrown the unit away.They are trying to clean the countertop, but they may want compensation if they need a repair or replacement.No additional information was available.
Additional Manufacturer Narrative
Not available.
Event or Problem Description
As per the reporter (consumer), waterpik-100 ultra was used and reported the unit sparked at the cord and base, then smoke came out.This report was received via other source from the united states of america on 23-mar-2026.The reporter (male) reported using waterpik-100 ultra.As per case description, "owned since (b)(6) 2024.Unit sparked at the cord and base, then smoke came out.No damage to people or property besides a burn on the consumer's shirt.Used daily.No additives and has not cleaned.Asking the consumer how he stored the unit and if the cord was wrapped around the unit.The consumer claims to have occasionally wrapped the cord around the unit for storage".No additional information was available.Correction: upon review, it was identified that additional information was inadvertently included in the previously submitted narrative.The narrative was updated to remove this information.This correction does not impact the reportability of the case.

• 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: 24942451
• Report Number: 1712259-2026-00004
• Device Sequence Number: 12159183
• Product Code: EFS
• UDI-Device Identifier: 00073950278195
• UDI-Public: 073950278195
• 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,Followup
• Report Date (Section B): 04/23/2026

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: WP-100
• Device Catalogue Number: NOT AVAIL.
• Device Lot Number: 221122AV
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2026
• Supplement Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 04/21/2026
• Supplement Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/22/2022
• 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