Model Number R5-032 |
Device Problems
No Apparent Adverse Event (3189); Insufficient Information (3190)
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Patient Problems
No Patient Involvement (2645); No Information (3190)
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Event Date 12/12/2018 |
Event Type
Injury
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Manufacturer Narrative
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Device disposition not presently known.
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Event Description
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A carbomedics reduced aortic valve was reportedly "used" but not implanted.The event is being reported in a conservative manner due to unknown relationship to the device and unknown patient impact.
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Event Description
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A carbomedics reduced r5-023 was "not implanted" in a patient.The site confirmed that the package was opened, but that it was not used and was thrown away.There was no patient involvement, and no event has been identified.
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Manufacturer Narrative
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It was reported that the device was discarded without being implanted.There was no patient impact or identified device issue.The event is deemed not valve related, and no further investigation is required.
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Search Alerts/Recalls
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