MAUDE Adverse Event Report: WATER PIK WATERPIK; TOOTHBRUSH

Model Number	STW-03
Medical Device Problem Code	Electrical Shorting (2926)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporting later than expected due to technical issues with the nextgen portal.
Event or Problem Description
Thermal event: charging puck "short circuited and nearly caught fire" only used twice daily.Charged once a week.No property damage or injury.

• Brand Name: WATERPIK
• Common Device Name: TOOTHBRUSH
• Manufacturer (Section D): WATER PIK; 1730 e. prospect rd; fort collins CO 80553 0001
• Manufacturer (Section G): WATER PIK; 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: 23019046
• Report Number: 1712259-2025-00003
• Device Sequence Number: 15907736
• Product Code: JEQ
• UDI-Device Identifier: 00073950318518
• UDI-Public: 00073950318518
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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: Administrator/Supervisor
• Remedial Action: Replace
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: STW-03
• Device Lot Number: 230706HAPA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/17/2025
• Initial Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2023
• 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
• Patient Sex: Male