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Model Number DYND20327 |
Device Problem
Contamination (1120)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/19/2021 |
Event Type
malfunction
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Manufacturer Narrative
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It was reported that hair was found within the piston irrigation syringe.To date, no information has been received to indicate that a user or a patient experienced a death, serious injury, medical intervention, follow-up care, or other adverse health impact associated with the reported problem/issue.A photo was provided for review and the reported problem/issue was confirmed.In an abundance of caution, and in response to an fda 483 issued for cfn (b)(4) on 22-jan-2024, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
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Event Description
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It was reported that hair was found within the piston irrigation syringe.
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Search Alerts/Recalls
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