inforMED
MalfunctionEFS

PHILIPS SONICARE CORDLESS POWER FLOSSER

Received Jun 16, 2026 · Event occurred Sep 30, 2024

Report 3026630-2026-100015 · MDR key 25521183

Device

Generic name

Oral Irrigator

Product problems

  • Overheating of Device

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

B3: EVENT DATE IS APPROXIMATE. D4: DEVICE SERIAL NUMBER AND MODEL 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 AND BURNT DAMAGE, 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'S CHARGER MELTED AND OBSERVED BURN MARKS WHILE CHARGING. THE CONSUMER STATED THAT THE DEVICE WAS HOT AND SMELLED LIKE BURNT PLASTIC. IT WAS CONFIRMED THAT NO INJURY OCCURRED. 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.