Model Number 6260096268 |
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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Event Description
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This spontaneous report was received on 13-jul-2015 from a consumer (age and gender unspecified) reporting on self from (b)(6).The medical history included sleep disorder.The concomitant medications included unspecified sleeping pills for sleep disorder.On an unspecified date, the consumer started using listerine total care dental floss, for oral hygiene (route dental, lot number 1654d, frequency and expiration date unspecified).After an unspecified duration, the consumer noticed the top of the floss package, which cuts the floss, broke off from the floss container.The consumer opened a lid to see the metal cutter and noticed the plastic insert was broken.The consumer also noticed that there was no piece of the floss available outside of the package to pull out and cut, so the consumer removed the cutter.Every time the consumer used the floss, the consumer had to pull the floss out and use a scissors to cut the floss.The consumer tried using second floss and noticed the same problem.The action taken with the device was unknown.This report had no adverse event.This report was considered a reportable malfunction in the united states.
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Manufacturer Narrative
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This foreign report is being submitted on 05-aug-2015 for a device that is considered same/similar to a us marketed device (listerine ultraclean mint floss).This is an initial submission for the first product in this case.The manufacturer report number for the second product in this case is 8041101-2015-00027.This closes out this report unless additional follow up information is received.
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Manufacturer Narrative
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This foreign report is being submitted on 22-sep-2015 for a device that is considered same/similar to a us marketed device (listerine ultraclean mint floss).This is a follow up submission for the first product in this case.The manufacturer report number for this submission is 8041101-2015-00026.The manufacturer report number for the second product in this case is 8041101-2015-00027.This closes out this report unless additional follow up information is received.
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Event Description
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This spontaneous report was received on 13-jul-2015 from a consumer (age and gender unspecified) reporting on self from (b)(6).The medical history included sleep disorder.The concomitant medications included unspecified sleeping pills for sleep disorder.On an unspecified date, the consumer started using listerine total care dental floss, for oral hygiene (route dental, lot number 1654d, frequency and expiration date unspecified).After an unspecified duration, the consumer noticed the top of the floss package, which cuts the floss, broke off from the floss container.The consumer opened a lid to see the metal cutter and noticed the plastic insert was broken.The consumer also noticed that there was no piece of the floss available outside of the package to pull out and cut, so the consumer removed the cutter.Every time the consumer used the floss, the consumer had to pull the floss out and use a scissors to cut the floss.The consumer tried using second floss and noticed the same problem.The action taken with the device was unknown.This report had no adverse event.This report was considered a reportable malfunction in the united states of america.Additional information was received 27-aug-2015.A review of the data revealed no prior complaints for the reported lot number.A device history record review was conducted, no non conformance or deviations were noted.A retain sample evaluation was conducted, visual inspection results were within specification.The analysis of product and complaint category will be managed through a monthly trending process.The complaint investigation was closed with a disposition of undetermined.Complaint trends will continue to be monitored.The case remains reportable malfunction in the united states of america.
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Search Alerts/Recalls
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