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

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 12/15/2023

Event Type  Injury  

Manufacturer Narrative

Product was not returned to confirm a malfunction has occurred.H3 other text : device not returned to manufacturer.

Event Description

A consumer reported that a philips one power toothbrush caught on fire.The consumer had injury reported but did not allege seeking medical treatment for their alleged injury.No property damage was reported.

• Brand Name: PHILIPS SONICARE
• Type of Device: PHILIPS ONE 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: imke overdevest ; 22100 bothell everett highway; bothell, WA 98021 ; 4254877000
• MDR Report Key: 18528004
• MDR Text Key: 333052373
• Report Number: 3026630-2024-00002
• 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

• Date FDA Received: 01/17/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/23/2023
• 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