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Catalog Number 0408731000 |
Device Problem
Material Split, Cut or Torn (4008)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/01/2019 |
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: 1 event was reported for this quarter. product return status: 1 device was not available for evaluation. additional information: 1 device is labeled for single-use.1 device was not reprocessed and reused.Device not available for evaluation.
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Event Description
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This report summarizes 1 malfunction event in which the device had material that was split, cut, or torn due to external or internal forces.1 event had patient involvement; no patient impact.
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Search Alerts/Recalls
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