inforMED
InjuryEFS

PHILIPS SONICARE

Received Jan 3, 2018 · Event occurred Dec 31, 2017

Report 3026630-2018-00010 · MDR key 7161797

Device

Generic name

Airfloss Pro/ultra

Model number

HX8340

Product problems

  • Missing Value Reason
  • Missing Value Reason

Patient

Not reported

  • Eye Injury
  • Eye Injury

Narrative

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE AIR FLOSS WAS NOT PROVIDED. DEVICE MANUFACTURING DATE NOT AVAILABLE DUE TO THE AIR FLOSS NOT BEING RETURNED.

Description of Event or Problem

CONSUMER CALLED STATING THAT THE NOZZLE CAME OFF OF THEIR AIRFLOSSPRO/ULTRA AND THEY GOT PHILIPS SONICARE SOLUTION IN THEIR EYES. SOUGHT MEDICAL TREATMENT FOR SCRATCHED CORNEA.

Additional Manufacturer Narrative

PRODUCT WAS NOT RETURNED TO CONFIRM A MALFUNCTION HAS OCCURRED. THE SAFETY DATA SHEET WAS SENT TO THE CUSTOMER INDICATING THAT THE (B)(6) MOUTHWASH MAY RESULT IN EYE IRRITATION OR REDNESS AND TO RINSE WITH WATER IMMEDIATELY, BUT NO IMMEDIATE MEDICAL OR SPECIAL TREATMENT NEEDED.