This spontaneous report was received on (b)(6) 2015 from a consumer (age and gender unspecified) reporting on self from (b)(6).On an unspecified date, the consumer used reach floss waxed 55yd,once (route: dental, lot number 2524d, expiration date and indication unspecified).During the first use, the cutter came off the container while the consumer was pulling out the string.This report had no adverse event and the action taken with the device was unknown.This report was considered a reportable malfunction in the united states of america.
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This spontaneous report was received on (b)(6) 2015 from a consumer (age and gender unspecified) reporting on self from (b)(6).On an unspecified date, the consumer used reach floss waxed 55yd, once (route: dental, lot number 2524d, expiration date and indication unspecified).During the first use, the cutter came off the container while the consumer was pulling out the string.This report had no adverse event and the action taken with the device was unknown.This report was considered a reportable malfunction in the united states of america.Additional information was received on 09-feb-2016.A review of complaint data revealed no unfavorable trends for the reported lot number.Analysis of the product and complaint category will be managed through the monthly trending process.Device history records were reviewed and no deviations or non-conformances were found.A visual inspection was performed on the retained samples and all results met specification.Based on the investigation results, there is no evidence that a device malfunction occurred.Based on the available information, the device was used for intended treatment.The complaint investigation was closed with a disposition of undetermined.Complaint trends will continue to be monitored.This report had no adverse event.This report remains as a reportable malfunction in the united states of america.
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