Model Number 8137109108USA |
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 Date 01/29/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.Patient id, date of birth and weight were not provided for reporting.(b)(4).A review of the device history records has been requested.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.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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The metal clip (cutter) broke off (separated) from one of the containers of dental floss.
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.A manufacturing investigation was performed for the subject device, 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.Device history records review was completed.No non conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition and product was manufactured per specification.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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