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

Model Number	WP-100
Health Effect - Clinical Codes	Abscess (1690); Bacterial Infection (1735)
Date of Event	02/05/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Unit in question has not yet been returned for testing and evaluation.Device in question has not been received.
Event or Problem Description
Per the customer.Claims use of product has caused an abcess in her gum.Claims inadequate drainage of the water pathway allowed bacteria to develop in the unit and alleges this bacteria was forced into her gums.She describes a visible buildup as occurring in the handle assembly.She says a typical use cycle consists of using the classic jet tip at pressure settings varying from 3-5.

• Brand Name: WATERPIK WATER FLOSSER
• Common Device Name: ORAL IRRIGATOR
• Manufacturer (Section D): WATER PIK, INC.; 1730 east prospect road; fort collins CO 80553 0001
• MDR Report Key: 5427387
• Report Number: 0001712259-2016-00002
• Device Sequence Number: 13037622
• Product Code: EFS
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/10/2016

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 Lot Number: JX11J08
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2016
• Initial Report FDA Received Date: 02/10/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 40 YR