FDA Adverse Event
Malfunction
Summary report: N
PHILIPS ONE
MDR report key: 25333473
·
Received May 29, 2026
Report
- Report Number
- 3026630-2026-100006
- Event Type
- Malfunction
- Date Received
- May 29, 2026
- Date of Event
- June 20, 2025
- Report Date
- May 29, 2026
- Manufacturer
- PHILIPS ORAL HEALTHCARE, LLC
- Product Code
- JEQ
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
B3: THE EVENT DATE IS APPROXIMATE. PRODUCT WAS NOT RETURNED FOR EVALUATION TO CONFIRM A MALFUNCTION OCCURRED. REPORTABILITY WAS REASSESSED DUE TO FDA FEEDBACK. REASSESSMENT DETERMINED THIS COMPLAINT TO BE AN OUT OF CAUTION REPORTABLE MALFUNCTION DUE TO POTENTIAL FOR HARM WHEN ALLEGED ¿EXPLODED¿ OR ¿MELTED¿ BY CONSUMER.
Description of Event or Problem · 0
A CONSUMER REPORTED THAT A PHILIPS ONE POWERED TOOTHBRUSH EXPLODED AND MELTED. NO INJURIES WERE REPORTED. CONSUMER REPORTED THAT THE TABLES WERE SCRATCHED RELATED TO THE ALLEGATION OF PHILIPS ONE POWERED TOOTHBRUSH EXPLODED AND MELTED. DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, IT CANNOT BE DETERMINED WHETHER THE DEVICE FAILED TO MEET SPECIFICATION AND/OR CAUSED OR CONTRIBUTED TO THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 166364 | PHILIPS ONE | POWERED TOOTHBRUSH | JEQ | PHILIPS ORAL HEALTHCARE, LLC | HY1100/03 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |