MAUDE Adverse Event Report: WATER PIK, INC. WATER PIK ULTRA; ORAL IRRIGATOR

Model Number	WP-100
Health Effect - Clinical Code	Tooth Fracture (2428)
Date of Event	01/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer stated that she purchased wp-100 from local (b)(6) on (b)(6) 2019.She uses the unit 2-3 times per week and was using it at pressure level 10.Stated that as she was using it, the crown/cap on her from tooth chipped at an angle.She is seeking a refund for the flosser and potential reimbursement to have the tooth fixed.Refund for unit has been submitted and she will be visiting dentist next week to get an estimate on cost to fix tooth.

• Brand Name: WATER PIK ULTRA
• Common Device Name: ORAL IRRIGATOR
• Manufacturer (Section D): WATER PIK, INC.; 1730 east prospect road; fort collins CO 80553 0001
• Manufacturer Contact: jeffrey dornoff ; 1730 east prospect road; fort collins, CO 80553-0001 ; 9702217062
• MDR Report Key: 13460245
• Report Number: 0001712259-2022-00001
• Device Sequence Number: 3895732
• Product Code: EFS
• UDI-Device Identifier: 00073950278195
• UDI-Public: 00073950278195
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 02/04/2022

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: WP-100
• Device Catalogue Number: WP-100W
• Device Lot Number: 180504CJ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2022
• Initial Report FDA Received Date: 02/04/2022
• Was Device Evaluated by Manufacturer? (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: Female