A review of the device history record is not possible as no lot number was provided.The actual complaint product was not returned for evaluation.Root cause could not be determined.All information reasonably known as of 14 sep 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.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 an unknown number of patients.This is the first of three reports.Refer to 9611594-2020-00181 for the second report.Refer to 9611594-2020-00182 for the third report.It was reported that the "button fell off when the device was applied." the button is the anchor.No patient injury was reported.Additional information has been requested but not yet received.
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