This spontaneous report was received on (b)(6) 2017 from a consumer (age and gender unspecified) reporting on self from united states of america.On an unspecified date, the consumer started using reach access daily flosser (unflavoured), dentally, for oral hygiene (lot number, frequency and expiration date unspecified).After an unspecified duration, in (b)(6) 2017, the handle of the flosser broke.It was reported that the flosser head kept popping out of the handle after getting through one tooth or sometimes it would last up to two teeth.This report had no adverse event and the action taken with the device was unknown.Lot number was not reported therefore a batch record review or retain analysis could not be requested or a lot trend analysis performed.The analysis for this product and complaint category will be managed through monthly trending process.The complaint investigation was closed with a disposition of undetermined.Based on the information available, the device was used for intended treatment.This report was considered a reportable malfunction in the united states of america.
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