PHILIPS SONICARE CORDLESS POWER FLOSSER 3000 SERIES
Received Jun 15, 2026 · Event occurred Apr 30, 2026
Report 3026630-2026-100014 · MDR key 25513315
Device
Generic name
Oral Irrigator
Manufacturer
Philips Oral Healthcare, LlcModel number
HX3826/21Catalog number
HX3826
Product problems
- Overheating of Device
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
B3: THE EVENT DATE IS APPROXIMATE. D4: THE DEVICE SERIAL NUMBER WERE NOT PROVIDED. H4: MANUFACTURE DATE NOT PROVIDED. 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. REASSESSMENT BASED ON FDA FEEDBACK. THE ALLEGED MALFUNCTION OF HEAT BUILD-UP AT THE CHARGING INTERFACE, DESCRIBED AS MELTING, HAS THE POTENTIAL TO CAUSE SERIOUS INJURY IF IT REOCCURS. THEREFORE, THE CASE HAS BEEN REASSESSED AS A REPORTABLE MALFUNCTION.
Description of Event or Problem
IT WAS REPORTED THAT A PHILIPS SONICARE CORDLESS POWER FLOSSER 3000 SERIES MELTED WHILE CHARGING. NO INJURY WAS REPORTED. 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.