inforMED
InjuryEFS

PHILIPS SONICARE

Received Oct 25, 2018 · Event occurred Oct 4, 2018

Report 3026630-2018-00358 · MDR key 8004295

Device

Generic name

Airfloss Pro/ultra

Model number

HX8340

Product problems

  • Patient Device Interaction Problem
  • Patient Device Interaction Problem

Patient

Not reported

  • Patient Problem/Medical Problem
  • Patient Problem/Medical Problem

Narrative

Additional Manufacturer Narrative

CONSUMER EXPERIENCED GINGIVAL INFLAMMATION. COMPLAINT RECEIVED FROM (B)(6).

Description of Event or Problem

CONSUMER CALLED STATING THAT THEY DEVELOPED GINGIVAL INFLAMMATION FROM USING AIRFLOSS. MEDICAL ATTENTION WAS SOUGHT FROM A DENTIST.

Additional Manufacturer Narrative

ADDITIONAL ACCESSORIES RETURNED AND EVALUATED WITH NO DEFECTS OR MALFUNCTIONS FOUND: PART NUMBER: DATE CODE: DESCRIPTION: HX6100; 180521 2B; TRITON BASE CHARGER; HX803X; 180219-02; AIRFLOSS PRO/ULTRA INTERDENTAL NOZZLE (QTY: 2). THE ROOT CAUSE OF THE CUSTOMER'S COMPLAINT COULD NOT BE DETERMINED.