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 13-dec-2019 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 three different incidences, which were associated with separate units, involving three different events.This is the first of three reports.Refer to 9611594-2019-00251 for the second event.Refer to 9611594-2019-00252 for the third event.It was reported the trans abdominal bolsters are falling off causing the feeding tube to become dislodged and leak.There was no reported patient injury.Additional information received 21-nov-2019 stated that some have fallen off with-in days of insertion.The physician notes there have been least three incidences of the bolsters falling off prior to the 2-week.No additional information was provided.
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