inforMED
InjuryEFS

PHILIPS SONICARE

Received Jan 18, 2022 · Event occurred Jan 6, 2022

Report 3026630-2022-00008 · MDR key 13287440

Device

Generic name

Airfloss Airfloss Pro/ultra

Model number

HX8481

Catalog number

HX8481/04

Product problems

  • Patient Device Interaction Problem
  • Patient Device Interaction Problem

Patient

Unknown

  • Erosion
  • Erosion

Narrative

Additional Manufacturer Narrative

THE EVENT DATE IS APPROXIMATE. THE DEVICE SERIAL NUMBERS OR MANUFACTURING NUMBERS WERE NOT PROVIDED. THE COMPLAINT WAS RECEIVED FROM A CONSUMER IN (B)(6). MANUFACTURE DATE NOT PROVIDED OR IDENTIFIABLE. ANALYSIS RESULTS: PRODUCT IS NOT RETURNED TO CONFIRM A MALFUNCTION HAS OCCURRED. PRODUCT NOT RETURNED TO MANUFACTURER.

Description of Event or Problem

A CONSUMER ALLEGED THAT THEIR AIRFLOSS PRO/ULTRA CAUSED THEIR GUM RECESSION.