InjuryEFS
PHILIPS SONICARE
Received Oct 22, 2021 · Event occurred Oct 5, 2021
Report 3026630-2021-10041 · MDR key 12683049
Device
Generic name
Airfloss Pro/ultra
Manufacturer
Philips Oral Healthcare, LlcModel number
HX8440Catalog number
HX8331/01
Product problems
- Patient Device Interaction Problem
- Patient Device Interaction Problem
Patient
Unknown
- Erosion
- Erosion
Narrative
Additional Manufacturer Narrative
CORRECTION OF ANALYSIS RESULTS: THE CAUSE OF THE CUSTOMERS COMPLAINT COULD NOT BE DETERMINED AS NO FAULT WAS FOUND WITH THE RETURNED DEVICE.
Additional Manufacturer Narrative
THE OUTCOME ATTRIBUTED TO ADVERSE EVENT WAS GUM INJURY. THE EVENT DATE IS APPROXIMATE. ANALYSIS RESULTS: THE ROOT CAUSE OF THE CUSTOMER¿S COMPLAINT WAS MOLD IN THE WATER LINE RESULTING RESTRICTED WATER FLOW.
Description of Event or Problem
A CONSUMER REPORTED THAT THEIR AIRFLOSS PRO/ULTRA CAUSED INJURY IN GUMS AND REQUIRED A GUM GRAFTING.