The actual complaint product was not returned for evaluation.Root cause could not be determined.The device history record for lot aa8029r05 was reviewed and the product was produced according to product specifications.All information reasonably known as of 21 mar 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 halyard health complaint database and identified as complaint (b)(4).
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It was reported that the anchor sutures for the gastropexy broke two hours after placement.The hospital alleges that as a result of the breaks, the patient developed peritonitis and required surgical intervention.Per additional information received 20 mar 2019, the patient's surgical intervention was successful and the patient is "safe.".
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