MAUDE Adverse Event Report: PHILIPS SONICARE; FLEXCARE POWER TOOTHBRUSH

Model Number HX6960

Device Problems Mechanical Problem (1384); Appropriate Term/Code Not Available (3191)

Patient Problem Vomiting (2144)

Event Date 08/10/2021

Event Type  malfunction  

Manufacturer Narrative

The event date is approximate.Customer contact information and mailing address were not provided.

Event Description

The consumer alleged that their flexcare power toothbrush metal pieces came out of toothbrush during use.No serious injury was reported.

Manufacturer Narrative

Analysis results: the root cause of the customer's complaint could not be determined as no functional fault could be found with the device.

• Brand Name: PHILIPS SONICARE
• Type of Device: FLEXCARE POWER TOOTHBRUSH
• MDR Report Key: 12317055
• MDR Text Key: 266378841
• Report Number: 3026630-2021-10029
• 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
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: HX6960
• Device Catalogue Number: HX6921/04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2021
• Distributor Facility Aware Date: 08/10/2021
• Initial Date Manufacturer Received: 08/10/2021
• Initial Date FDA Received: 08/12/2021
• Supplement Dates Manufacturer Received: 09/09/2021
• Supplement Dates FDA Received: 09/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2018
• 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