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 07-apr-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 received a single report that referenced three different incidences, which were associated with separate units, involving three different events.This is the third of three reports.Refer to 9611594-2020-00061 for the first event.Refer to 9611594-2020-00062 for the second event.It was reported that two out of three sutures broke during the gastrostomy tube insertion procedure.There was no reported injury.
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