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

Model Number HX939W

Device Problem Temperature Problem (3022)

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

Event Date 01/04/2022

Event Type  malfunction  

Manufacturer Narrative

The event date is approximate.

Event Description

A consumer alleged that their diamond clean power toothbrush exploded during charge.No property damage and no injury were reported.

Manufacturer Narrative

Analysis results: the cause of the customers complaint could not be determined as no evidence of a battery issue or explosion was found with the device.

• Brand Name: PHILIPS SONICARE
• Type of Device: DIAMONDCLEAN 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: 13242959
• MDR Text Key: 285823593
• Report Number: 3026630-2022-00007
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: HX939W
• Device Catalogue Number: HX9332/10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2022
• Date Manufacturer Received: 02/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2019
• 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