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 04-mar-2021 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.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical, inc.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 three different incidences, which were associated with separate units, involving three different events.This is the third of three reports.Refer to 9611594-2021-00032 for the first event.Refer to 9611594-2021-00033 for the second event.It was reported the tubes fractured down where the g-tube and j-tube connect.The patient called and said when they went to irrigate the j-port, there was return via the g port.When it was replaced in the irl, it was noted that the "side wall was blown out on the tube in the distal portion (in stomach)".There was no reported injury.
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