Model Number 381370092179 |
Device Problem
Detachment Of Device Component (1104)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.(b)(4).Product was returned for investigation for an broken cutter.Upon visual evaluation of the returned device, it was noted that the metal cutter was completely separated from the insert assembly.It is unknown how the product was being used at the time.Device history records review could not be completed without lot number.Additional evaluation is pending from manufacturing site.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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Consumer called and stated that the upon first use of reach j&j floss, the part that holds the floss popped off.The consumer returned the device and the consumer returned field sample was noted with metal cutter completely separated from the insert assembly.
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.Date of manufacturing is not available for reporting since a partial package without lot number was returned.Returned sample was evaluated, it was confirmed that the metal cutter was completely separated from the insert assembly.It is unknown how the product was being used at the time.At this time, no conclusion is able to be drawn about the cause of the metal cutter separation as no additional information is available regarding the use of the device.If information is obtained that was not available for this follow-up medwatch, an additional follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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