Catalog Number 3500000710 |
Device Problem
Unintended System Motion (1430)
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Patient Problems
Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2020 |
Event Type
malfunction
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Manufacturer Narrative
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This mdr is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.The device was not made available for testing by the customer; no cause was established.There was no remedial action taken.This device is not labeled for single use.
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Event Description
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This report summarizes 1 malfunction event, where it was reported.There was patient involvement; the patient experienced pain.
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Manufacturer Narrative
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(b)(4).
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Event Description
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This report summarizes 1 malfunction event, where it was reported the device had phantom motion.There was patient involvement; the patient experienced pain.
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Manufacturer Narrative
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Corrected to "product problem".
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Event Description
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This report summarizes 1 malfunction event, where it was reported the device had phantom motion.There was patient involvement; the patient experienced pain.
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Search Alerts/Recalls
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