A review of the device history record is not possible as no lot number was provided.The sample is reported to be available, but has not yet been received by the manufacturer.All information reasonably known as of 25 aug 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.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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It was reported that the device was removed via traction and the internal bumper separated from the peg tube and was retained.There was a split in the tube close to skin level.No patient injury or medical treatment was reported.The device was inserted in (b)(6) 2020.Additional information received 16-aug-2021 indicated "on traction removal of a patient's corflopeg tube the internal bumper separated from the peg tube and was retained in the stomach.Patient to be monitored for signs of obstruction and if experiences any abdominal pain, abdominal distention, nausea, vomiting, altered bowel habits to arrange an urgent medical/hospital review.'" additional information received 17-aug-2021 indicated "during removal of peg tube, internal bumper came detached from peg tube and was retained in patient." further additional information has been requested but not yet received.
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