PHILIPS SONICARE
Received Nov 14, 2017 · Event occurred Oct 25, 2017
Report 3026630-2017-00280 · MDR key 7030401
Device
Product problems
- Missing Value Reason
- Missing Value Reason
Patient
Not reported
- Laceration(s)
- Patient Problem/Medical Problem
- Laceration(s)
- Patient Problem/Medical Problem
Narrative
Additional Manufacturer Narrative
INTERNAL INSPECTION SHOWS NO ISSUE WITH UNIT. CHARGER IS OPERATING WITHIN SPECIFICATION. THERE IS A WARNING IN THE DFU UNDER IMPORTANT, CAUTION ON PG. 8 THAT STATES, "TO AVOID PHYSICAL INJURY, DO NOT DIRECT THE SPRAY UNDER THE TONGUE OR INTO THE EAR, NOSE, EYE OR OTHER SENSITIVE AREA." THE ROOT CAUSE OF THE CUSTOMER'S COMPLAINT COULD NOT BE DETERMINED.
Additional Manufacturer Narrative
LACERATIONS ON THE TONGUE MADE LEAD TO PERMANENT DAMAGE TO A BODY STRUCTURE.
Description of Event or Problem
CONSUMER COMPLAINED THE STREAM OF THE AIRFLOSS CAUSED BLEEDING AND A BLOOD BLISTER ON THEIR TONGUE. MEDICAL ATTENTION SOUGHT.