MAUDE Adverse Event Report: PHILIPS ORAL HEALTHCARE, LLC PHILIPS SONICARE; PROTECTIVECLEAN POWER TOOTHBRUSH

Model Number HX685T

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Tooth Fracture (2428)

Event Date 12/05/2019

Event Type  Injury  

Manufacturer Narrative

Outcomes to adverse event: the reported injury was a fine crack on the consumer's teeth.Report source: complaint received from (b)(6).

Event Description

A consumer alleged that a fine crack on their teeth during use of the protective clean power toothbrush.

Manufacturer Narrative

The product model was identified; revised lot # from not applicable (na) to no information (ni).Patient phone number was identified.Analysis results: product was not returned to confirm a malfunction has occurred.

• Brand Name: PHILIPS SONICARE
• Type of Device: PROTECTIVECLEAN POWER TOOTHBRUSH
• Manufacturer (Section D): PHILIPS ORAL HEALTHCARE, LLC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer (Section G): PHILIPS ORAL HEALTHCARE, LLC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer Contact: chieu yeung ; 22100 bothell everett highway; bothell, WA 98021 ; 4254877000
• MDR Report Key: 9537036
• MDR Text Key: 173556228
• Report Number: 3026630-2019-00082
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup

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
• Device Operator: Lay User/Patient
• Device Model Number: HX685T
• Device Catalogue Number: HX6877/54
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/05/2019
• Initial Date Manufacturer Received: 12/06/2019
• Initial Date FDA Received: 12/31/2019
• Supplement Dates Manufacturer Received: 03/04/2020
• Supplement Dates FDA Received: 03/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other