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

Catalog Number TOOTHBRUSH_ACCESSORIES_SU

Device Problem Excessive Heating (4030)

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

Event Date 04/16/2024

Event Type  malfunction  

Event Description

The consumer alleged that the toothbrush base exploded and caught fire.There was no injury or property damage alleged.

Manufacturer Narrative

The event date is approximate.Product was not returned to confirm a malfunction has occurred.

• Brand Name: PHILIPS SONICARE
• Type of Device: SONICARE TOOTHBRUSH CHARGER
• 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: ellen patterson ; 22100 bothell everett highway; bothell, WA 98021 ; 4254877000
• MDR Report Key: 19183425
• MDR Text Key: 341469677
• Report Number: 3026630-2024-00023
• 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

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 Catalogue Number: TOOTHBRUSH_ACCESSORIES_SU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: No
• 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