MAUDE Adverse Event Report: WATER PIK INC WATER PIK SONIC FUSION FLOSSING TOOTHBRUSH; ORAL IRRIGATOR

Model Number SF-02CD012-3

Device Problems Electrical /Electronic Property Problem (1198); Fire (1245)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/16/2020

Event Type  malfunction  

Event Description

Claim initiated by national subrogation services and communicated to sonic fusion recall inbox sonicfusion-return@waterpik.Com.Subrogation correspondence claims smoke/fire damage in multiple areas of household.No personal injury communicated in claim.Per "independent expert report" ((b)(6) forensic engineering) it was concluded "an electrical failure within the water pik electric toothbrush base, which has been recalled through the fda as a potential fire and sparking hazard; cannot be eliminated as the ignition source for the loss date fire." sonic fusion recall packet issued 7/3/2018 and 7/30/2018 ((b)(6) tracking (b)(4), (b)(6) tracking (b)(4))-agent notes attached to 7/30/2018 interaction indicate "customer on vacation until sep.Have not rcvs sf unit back yet." (b)(6) contacted customer service 2/1/2019 after claimed date of loss (12/29/2018) asking if device (sf-02c1804112{sic}ap) is safe ((b)(6) asks verbatim if "that means it was manufactured in april 12, 2018").(b)(6) was evasive in describing how he came to own the device; "just came across it." during the call, (b)(6) identifies (b)(6) as purchaser, later refers to (b)(6) as the "owner." (b)(6) indicates he "doesn't necessarily want to return it," refuses return label.(b)(6) claims he "will check with the actual owner whether he wants to return it or not.Rep urges that owner should return it, (b)(6) identifies "he won't use it" referring to owner.Customer service has attempted to contact (b)(6) multiple times with no response.

• Brand Name: WATER PIK SONIC FUSION FLOSSING TOOTHBRUSH
• Type of Device: ORAL IRRIGATOR
• Manufacturer (Section D): WATER PIK INC; 1730 e. prospect road; fort collins CO 80553 0001
• Manufacturer (Section G): WATER PIK INC.; 1730 e. prospect rd; fort collins CO 80553 0001
• Manufacturer Contact: jeffrey dornoff ; 1730 e. prospect rd.; fort collins, CO 80553-0001 ; 9702217062
• MDR Report Key: 10550819
• MDR Text Key: 208329752
• Report Number: 0001712259-2020-00006
• Device Sequence Number: 1
• Product Code: EFS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: SF-02CD012-3
• Device Catalogue Number: SF-02CD012-3
• Device Lot Number: 180412AP
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/16/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/12/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 35 YR