JOHNSON & JOHNSON CONSUMER PRODUCTS JOHNSON AND JOHNSON FLOSS, MINT WAXED; DENTAL FLOSS
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Model Number 8137009217 |
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 23-oct-2015.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 (b)(6) -2015 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 (route: dental, lot number 3434d, frequency and expiration date unspecified) for general oral hygiene.After an unspecified duration, the consumer noticed that the metal cutter and attached piece of plastic broke off from the insert while dispensing, during use and while cutting the floss.The consumer had to open the lid to see the metal cutter.The consumer reported that the metal cutter was still intact to the piece of the plastic and it broke away from the insert.The cutter breakage included plastic insert parts.The consumer stated to have experienced this twice.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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Manufacturer Narrative
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The date of this submission is 26-nov-2015.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 (b)(6) 2015 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 (route: dental, lot number 3434d, frequency and expiration date unspecified) for general oral hygiene.After an unspecified duration, the consumer noticed that the metal cutter and attached piece of plastic broke off from the insert while dispensing, during use and while cutting the floss.The consumer had to open the lid to see the metal cutter.The consumer reported that the metal cutter was still intact to the piece of the plastic and it broke away from the insert.The cutter breakage included plastic insert parts.The consumer stated to have experienced this twice.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 12-nov-2015.A review of the lot trending data revealed no trend for the reported lot number.The field sample was not received.The retained sample was evaluated and met specifications for appearance.The review of the device history review demonstrated the product met specifications.The complaint investigation was closed with a disposition of undetermined.Complaint trends will continue to be monitored.This report remains a reportable malfunction case in the united states of america.
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Search Alerts/Recalls
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