inforMED
InjuryEFS

PHILIPS SONICARE

Received May 2, 2019 · Event occurred Apr 15, 2019

Report 3026630-2019-00032 · MDR key 8576016

Device

Generic name

Airfloss Ultra

Model number

HX8431

Product problems

  • Patient Device Interaction Problem
  • Patient Device Interaction Problem

Patient

Not reported

  • Tooth Fracture
  • Tooth Fracture

Narrative

Additional Manufacturer Narrative

THE CONSUMER ALLEGES THAT THEY LOST A FILLING FROM THEIR TEETH. EVENT DATE IS APPROXIMATE. THE SERIAL NUMBER IS NOT AVAILABLE BECAUSE THE PRODUCT WAS NOT RETURNED. THE PRODUCT WAS DISCARDED BY THE CONSUMER AND WILL NOT BE RETURNED TO THE MANUFACTURER. FOREIGN: COMPLAINT RECEIVED FROM (B)(6). THE PRODUCT WAS DISCARDED BY THE CONSUMER AND WILL NOT BE RETURNED TO THE MANUFACTURER. THE MANUFACTURING DATE IS NOT AVAILABLE BECAUSE THE PRODUCT WAS NOT RETURNED.

Description of Event or Problem

CONSUMER ALLEGES THAT THEY LOST A FILLING FROM THEIR TEETH WHEN USING THEIR SONICARE AIRFLOSS.