inforMED
InjuryEFS

PHILIPS SONICARE

Received Aug 1, 2018 · Event occurred Jul 28, 2018

Report 3026630-2018-00345 · MDR key 7741536

Device

Generic name

Airfloss

Model number

HX8111

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 STATED THEY EXPERIENCED GINGIVAL ISSUES. COMPLAINT RECEIVED FROM (B)(6).

Description of Event or Problem

CONSUMER CALLED STATING THAT THEY ARE EXPERIENCING GINGIVAL ISSUES FROM USING THE AIRFLOSS WHICH HAS MOLD THAT HAS FORMED IN INACCESSIBLE AREAS OF THE DEVICE.

Additional Manufacturer Narrative

PRODUCT WAS NOT RETURNED TO CONFIRM A MALFUNCTION HAS OCCURRED.