Model Number 0041803740 |
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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This foreign report is being submitted on 23-feb-2016 for a device product that is considered same/similar to a us marketed device (rereach j&j floss waxed 55yd).This closes out this report unless additional significant information is received.
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Event Description
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This spontaneous report was received on (b)(6) 2016 from a consumer reporting on self (age and gender unspecified) from (b)(6).On an unspecified date, the consumer started using reach floss cleanpaste original 32m (route: dental, lot number, expiration date, frequency, and indication unspecified).After an unspecified duration, the consumer noticed the cutter came off the container when the device was used.It was reported that the cutter guard of the floss came off the container every time the consumer tried to cut the string.This report had no adverse event and the action taken with the device was unknown.As the lot number was not provided, lot trend analysis, batch record review, and retain sample analysis could not be performed.The complaint investigation was closed with a disposition of undetermined.This report was considered a reportable malfunction in the united states of america.
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Manufacturer Narrative
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This foreign report is being submitted on 09-mar-2016 for a device product that is considered same/similar to a us marketed device (reach j&j floss waxed 55yd).This closes out this report unless additional significant information is received.
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Event Description
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This spontaneous report was received on (b)(6) 2016 from a consumer reporting on self (age and gender unspecified) from (b)(6).On an unspecified date, the consumer started using reach floss cleanpaste original 32m (route: dental, lot number, expiration date, frequency, and indication unspecified).After an unspecified duration, the consumer noticed the cutter came off the container when the device was used.It was reported that the cutter guard of the floss came off the container every time the consumer tried to cut the string.This report had no adverse event and the action taken with the device was unknown.As the lot number was not provided, lot trend analysis, batch record review, and retain sample analysis could not be performed.The complaint investigation was closed with a disposition of undetermined.This report was considered a reportable malfunction in the united states of america.Additional information was received on 23-feb-2016.This device was used for intended treatment.This report remains as a reportable malfunction in the united states of america.
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Search Alerts/Recalls
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