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Model Number 4402 |
Device Problem
Sharp Edges (4013)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/01/2020 |
Event Type
malfunction
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Manufacturer Narrative
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This mdr is part of the fda voluntary malfunction summary reporting program.3 devices were evaluated in the field and the issues were confirmed; 2 devices had broken/damaged components and 1 device had bent/deformed components.The devices were repaired and returned.There was no remedial action taken.These devices are not labeled for single use.
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Event Description
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This report summarizes 3 malfunction events, where it was reported there were accessible sharp metal edges.There was no patient involvement.
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Search Alerts/Recalls
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