SONICARE HX8140

Adverse Event reported on 10/13/2012

Device Attributes
AttributeValue
ManufacturerPHILIPS ORAL HEALTHCARE
Brand NameSONICARE
Device TypeAIRFLOSS
Product CodeJEQ
Model NumberHX8140
Catalog Number
Device Operator0LP
PHILIPS ORAL HEALTHCARE SONICARE AIRFLOSS   Back to Search Results
Model Number HX8140
Event Date 09/14/2012
Event Type  Other   Patient Outcome  Other
Event Description

(b)(6) 2012, consumer states that the unit chipped her tooth.

 
Manufacturer Narrative

(b)(6) 2012, consumer states that she had been using the product for about 3 weeks and a little piece of her tooth became loose and fell off. Consumer claims that she thinks the piece of tooth fell off because her teeth are older and fragile. Consumer states that the dentist put a filling in. Consumer was issued a refund for the product. Product was requested to be returned for evaluation. (b)(4) 2012, unit received for evaluation. (b)(4) 2012, failure analysis completed. Unit received in moderately used condition. Upon microscopic examination, the nozzle tip appears smooth with only minor irregularities from normal usage. Unit passes functional specifications and the nozzle appears normal. Root cause of customer complaint unknown.

 
Source: FDA