This spontaneous report was received on 15-mar-2017 from a consumer (age and gender unspecified) reporting on self from the united states of america.On an unspecified date, the consumer started using johnson and johnson floss, mint waxed dentally for oral hygiene (lot number 1446d, frequency and expiration date unspecified).After one week, the metal cutter broke off from plastic insert while dispensing the floss.The consumer mentioned that prior to the breakage the metal cutter was intact and consumer had opened the lid to see it.The breakage did not include plastic insert or any other part of container.The consumer mentioned to have attempted to reinsert the plastic insert back into the container but was unable to dispense the floss.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 15-mar-2017 from a consumer (age and gender unspecified) reporting on self from the united states of america.On an unspecified date, the consumer started using johnson and johnson floss, mint waxed dentally for oral hygiene (lot number 1446d, frequency and expiration date unspecified).After one week, the metal cutter broke off from plastic insert while dispensing the floss.The consumer mentioned that prior to the breakage the metal cutter was intact and consumer had opened the lid to see it.The breakage did not include plastic insert or any other part of container.The consumer mentioned to have attempted to reinsert the plastic insert back into the container but was unable to dispense the floss.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 27-mar-2017.The product code updated from reach johnson and johnson floss waxed mint usa refwmtus to reach johnson and johnson floss waxed mint 200yd usa 381370092346 8137009234usa.On 27-mar-2017, one reach mint waxed was received used.On 07-apr-2017, it was visually examined according to product specification and test method by appearance and sample was compared against the visual standard of the product.The lot number 1446d was identified.The device received as field sample does not meet specifications as it was received without cutter.A review of complaint data revealed no unfavorable trends for the reported lot number.Visual inspection was performed on the retain samples and all results met specification.Device history records were reviewed and no deviations or non-conformances were noted.This case was updated from a reportable malfunction to a non reportable malfunction based on the product and category.The analysis for the product complaint category will be managed through monthly trending process.Since evidence was found supporting the consumers allegations, this complaint investigation was closed as confirmed.Product met specification as documented in the records review and retained evaluation.Complaint trends will continue to be monitored.This report was reassessed as a non reportable malfunction case in the united states of america.
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