MAUDE Adverse Event Report: WATERPIK WATERPIK; ORAL IRRIGATION

Model Number	WF-04CD
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Not avail.
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 flossers-04cd sidekick.As per description, " wf-04cd010-1, (b)(6) charger has a hole burned through".Reporter stated, "the adaptor suddenly burnt while it was not in use but connected to gfci outlet.We were very scared with the issue and need your replacement.We called electrician to check all of our brand-new electricity system and concluded it is a waterpik product defect.Used the unit 3-4 times per week.No additives.Has never cleaned".Medical history and concomitant medication - unknown.
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 flossers-04cd sidekick.As per description, " wf-04cd010-1 200924ap charger has a hole burned through".Reporter stated, "the adaptor suddenly burnt while it was not in use but connected to gfci outlet.We were very scared with the issue and need your replacement.We called electrician to check all of our brand-new electricity system and concluded it is a waterpik product defect.Used the unit 3-4 times per week.No additives.Has never cleaned".Medical history and concomitant medication - unknown.Follow-up report 1: this case was received on 16-dec-2025 and was submitted to fda on 06-jan-2026.In the version submitted, the manufacturer contact details were incorrectly added.We are therefore submitting a follow up report to amend the manufacturer details.
Additional Manufacturer Narrative
Not available.

• 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: 23973282
• Report Number: 1712259-2026-00001
• Device Sequence Number: 13014989
• Product Code: EFS
• UDI-Device Identifier: 00073950224895
• UDI-Public: 073950224895
• 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): 01/09/2026

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-04CD
• Device Catalogue Number: NOT AVAIL.
• Device Lot Number: 200924AP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2025
• Supplement Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/24/2020
• 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: Unknown