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Catalog Number 66800472 |
Device Problem
Material Split, Cut or Torn (4008)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/18/2022 |
Event Type
malfunction
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Event Description
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It was reported that the strain relief broken at footswitch, exposing wires.As this was noticed in a non-surgical environment, there was not any patient involved.
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Manufacturer Narrative
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Nternal complaint reference #: (b)(4).
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Manufacturer Narrative
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The information received by the manufacturer has been re-evaluated for mdr reporting and it was determined that this case does not meet the threshold for reporting and is a non-reportable event.Split, cut or torn material may require use of a backup device to continue therapy.This event did not result in a death or serious injury, nor would it be likely to cause or contribute to a death or serious injury if it were to recur.This event is considered not reportable pursuant to 21 cfr §803.
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Search Alerts/Recalls
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