Catalog Number 5100015270 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/31/2024 |
Event Type
malfunction
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Manufacturer Narrative
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This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events (b)(4) events were reported for this quarter.Product return status (b)(4) devices were received.(b)(4) device investigation types have not yet been determined.Additional information (b)(4)devices were not labeled for single-use.(b)(4) devices were not reprocessed or reused.
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Event Description
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This report summarizes (b)(4) malfunction events in which the device had a component detach.- (b)(4) events had no patient involvement; no patient impact.
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Search Alerts/Recalls
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