InjuryEFS
PHILIPS SONICARE
Received Dec 31, 2019 · Event occurred Dec 5, 2019
Report 3026630-2019-00083 · MDR key 9537065
Device
Generic name
Airfloss
Manufacturer
Philips Oral Healthcare, LlcModel number
HX8240Catalog number
HX8211/02
Product problems
- Patient Device Interaction Problem
- Patient Device Interaction Problem
Patient
Not reported
- Tooth Fracture
- Tooth Fracture
Narrative
Additional Manufacturer Narrative
OUTCOMES TO ADVERSE EVENT: THE CONSUMER REPORTED THAT THE FRONT OF A MOLAR BROKE OFF. REPORT SOURCE: COMPLAINT RECEIVED FROM THE (B)(6).
Description of Event or Problem
A CONSUMER ALLEGED THAT THE AIRFLOSS CAUSED THE FRONT OF A MOLAR TO BREAK OFF DURING USE.
Additional Manufacturer Narrative
CORRECTION OF THE PRODUCT MODEL NUMBER; REVISED LOT # FROM NOT APPLICABLE (NA) TO NO INFORMATION (NI). ANALYSIS RESULTS: THE ROOT CAUSE OF THE CUSTOMER'S COMPLAINT COULD NOT BE DETERMINED AS THE DEVICE OPERATES WITHIN SPECIFICATION.