This spontaneous report was received on (b)(6) 2016 from a male consumer (age unspecified) reporting on self from the united states of america.The medical history and the concomitant medications were not reported.On an unspecified date, the consumer started using listerine ultraclean access dental flosser dentally, flosser head used multiple times (intentional device misuse) (indication, lot number and expiration date unspecified).After an unspecified duration, the consumer noticed that flosser head fell off in his mouth from the handle in two separate uses during flossing.It was reported that the handle did not break in both the uses.The consumer mentioned to have used flosser head multiple times and washed after each use.The action taken with the device was unknown.This report was assessed as non-serious and company causality was assessed as related.Consumer did not provide product lot number therefore, a batch record review could not be requested or a lot trend analysis performed.Based on the information available, the device was used for intended treatment.The analysis for the product complaint category will be managed through monthly trending process.The complaint investigation was closed with a disposition of undetermined.This report was considered a reportable malfunction in the united states of america.
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