Catalog Number 5407120452 |
Device Problem
Flaked (1246)
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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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Event Description
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This report summarizes 41 malfunction events in which the device had paint chips missing.41 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.Reported events: 41 events were reported for this quarter.Product return status: 41 devices were evaluated in the field.Additional information: 41 devices were not labeled for single-use.41 devices were not reprocessed or reused.
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Event Description
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This report summarizes 40 malfunction events in which the device had paint chips missing.40 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.Corrected data: b5, h6, h11.41 events were previously reported during the reporting quarter; however, 1 event was reported in error.40 previously reported events are included in this follow-up record.Product return status.40 devices were not labeled for single-use.40 devices were not reprocessed or reused.
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Search Alerts/Recalls
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