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Catalog Number 120002 |
Device Problem
Break (1069)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/01/2023 |
Event Type
malfunction
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Event Description
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It was reported that the device had physical damage.Patient involvement is unknown.
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Manufacturer Narrative
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Other, other text: b3: date of event is unknown, no information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
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Event Description
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Additional information received via email.Event occurred while device was taken to the emergency room.Event date was updated from unknown to 01-march-2023.There was no patient injury and no medical intervention,.
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Search Alerts/Recalls
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