InjuryEFS
PHILIPS SONICARE
Received Feb 3, 2020 · Event occurred Jan 17, 2020
Report 3026630-2020-00010 · MDR key 9663163
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
REVISED LOT # FROM NOT APPLICABLE (NA) TO NO INFORMATION (NI). ANALYSIS RESULTS: PRODUCT WAS NOT RETURNED TO CONFIRM A MALFUNCTION HAS OCCURRED.
Additional Manufacturer Narrative
THE OUTCOME ATTRIBUTED TO AE WAS DAMAGE TO THE CONSUMER'S DENTAL CROWN. THE EVENT DATE IS APPROXIMATE. REPORT SOURCE: COMPLAINT RECEIVED FROM (B)(6).
Description of Event or Problem
A CONSUMER REPORTED THAT THEIR AIRFLOSS HAS SO MUCH PRESSURE THAT IT HAS BROKEN OUT A CROWN.