Model Number 5100131000 |
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 09/30/2020 |
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: 4 events were reported for this quarter.Product return status: 1 device was received.2 devices were not available for evaluation.1 device investigation type has not yet been determined.Event confirmation status: 1 reported event was confirmed.Evaluation results: 1 device was found to be affected by a missing retainer.4 devices were not labeled for single-use.4 devices were not reprocessed or reused.
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Event Description
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This report summarizes 4 malfunction events in which the device had a component detach.4 events had no patient involvement; no patient impact.
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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.Supplemental rationale: 4 previously reported events are included in this follow-up record.Product return status: 2 devices were received.2 devices were not available for evaluation.
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Event Description
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This report summarizes 4 malfunction events in which the device had a component detach.3 events had no patient involvement; no patient impact.1 event had patient involvement; no patient impact.
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Search Alerts/Recalls
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