The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.All information reasonably known as of 08-jan-2020 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical, inc.Represents all of the known information at this time.Avanos medical, inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical, inc.Complaint database and identified as complaint (b)(4).
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Avanos medical, inc.Received a single report that referenced six different incidences, which were associated with separate units, involving six different events.This is the fourth of six reports.Refer to 2026095-2021-00007 for the first event.Refer to 2026095-2021-00008 for the second event.Refer to 2026095-2021-00009 for the third event.Refer to 2026095-2021-00011 for the fifth event.Refer to 2026095-2021-00012 for the sixth event.It was reported that patient developed a pelvic infection right around where the catheter was inserted.No additional information was provided.
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