Avanos medical received a single report that referenced two different incidents, which were associated with separate units, involving two different patients.This is the first of two reports.Refer to 9611594-2018-00234 for the second patient.It was reported that the thread of a gastrointestinal anchor set snapped the next day following a gastrostomy operation.The thread snapped at all three positions.It was noted that there was no patient injury.
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Corrected data: lot number.The device history record for the reported lot number was reviewed and documented that the lot was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.All information reasonably known as of 04-jan-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.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).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical inc product is defective or caused serious injury.Show less.
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