inforMED
MalfunctionEFS

PHILIPS SONICRE

Received Oct 20, 2022 · Event occurred Sep 29, 2022

Report 3026630-2022-00148 · MDR key 15640039

Device

Generic name

Airfloss Nozzle

Catalog number

HX8232/08

Product problems

  • Detachment of Device or Device Component
  • Detachment of Device or Device Component

Patient

Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

THE EVENT DATE IS APPROXIMATE. THE COMPLAINT WAS RECEIVED FROM A CONSUMER IN JAPAN. PRODUCT WAS NOT RETURNED TO CONFIRM A MALFUNCTION HAS OCCURRED.

Description of Event or Problem

A CONSUMER REPORTED THAT THEIR AIRFLOSS NOZZLE TIP BROKE DURING USE. NO INJURY WAS ALLEGED. THE SIZE OF BROKEN PARTS ARE CONSIDERED A SMALL PART BREAK. THEREFORE, IT IS REASONABLY POSSIBLE THAT SMALL PARTS BREAK DURING USE COULD POSE A CHOKING HAZARD TO THE CONSUMER. THIS CASE IS BEING CONSERVATIVELY REPORTED.