inforMED
MalfunctionEFS

PHILIPS SONICARE

Received Feb 3, 2021 · Event occurred Feb 1, 2021

Report 3026630-2021-00013 · MDR key 11277044

Device

Generic name

Airfloss

Model number

HX8331

Catalog number

HX8331/12

Product problems

  • Temperature Problem
  • Temperature Problem

Patient

Not reported

  • No Consequences Or Impact To Patient
  • No Consequences Or Impact To Patient

Narrative

Additional Manufacturer Narrative

E1: THE CONSUMER'S CONTACT ADDRESS WAS IDENTIFIED AND UPDATED.

Additional Manufacturer Narrative

ANALYSIS RESULTS: PRODUCT WAS NOT RETURNED TO CONFIRM A MALFUNCTION HAS OCCURRED. H3 OTHER TEXT: PRODUCT NOT RETURNED TO MANUFACTURER.

Additional Manufacturer Narrative

THE EVENT DATE IS APPROXIMATE. THE SERIAL NUMBER AND UDI WERE NOT PROVIDED. THE CONSUMER'S CONTACT ADDRESS WAS NOT PROVIDED. THE MANUFACTURE DATE COULD NOT BE IDENTIFIED BASED ON AVAILABLE INFORMATION.

Description of Event or Problem

THE CONSUMER ALLEGED THAT THEIR AIFLOSS EXPLODED DURING TEST. THERE WAS NO INDICATED INJURY OR PROPERTY DAMAGE REPORTED.