JOHNSON & JOHNSON CONSUMER PRODUCTS JOHNSON & JOHNSON FLOSS, MINT WAXED; DENTAL FLOSS
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Model Number REFWMTUS |
Device Problem
Break (1069)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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The date of this submission is 07-apr-2016.This closes out this report unless other additional significant information is received.
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Event Description
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This spontaneous report was received on 18-mar-2016 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, (lot number 1815d, frequency and expiration date unspecified) dentally for an unknown indication.After an unspecified duration, when approximately half of the device had been used, the consumer noticed the floss cutter popped out during dispensing which the consumer reported as the razor gizmo being caught and pulled out.The consumer stated the spool was useless.This report had no adverse event and the action taken with the device was unknown.This report was considered as a reportable malfunction in the united states of america.
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Manufacturer Narrative
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The date of this submission is 02-may-2016.This closes out this report unless other additional significant information is received.
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Event Description
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This spontaneous report was received on 18-mar-2016 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, (lot number 1815d, frequency and expiration date unspecified) dentally for an unknown indication.After an unspecified duration, when approximately half of the device had been used, the consumer noticed the floss cutter popped out during dispensing which the consumer reported as the razor gizmo being caught and pulled out.The consumer stated the spool was useless.This report had no adverse event and the action taken with the device was unknown.This report was considered as a reportable malfunction in the united states of america.Additional information was received on 18-apr-2016.A review of complaint data revealed no unfavorable trends for the reported lot number.The analysis for this product and complaint category will be managed through monthly trending process.Device history records were reviewed and no deviations or non conformances were noted.Visual inspection was performed on the retain samples and all results met specification.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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Search Alerts/Recalls
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