The actual complaint product was not returned for evaluation.The device history record for the reported lot number, 30166109, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.Root cause could not be determined.All information reasonably known as of 26-aug-2022 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.
|
It was reported that one safety-pexy broke on the day of placement, (b)(6) 2022, and the other two remained.The next day, an x-ray was performed to verify placement and found that the remaining two safety-pexies were not present.X-ray visualized one t-bar floating in the stomach.The physician was going to send the patient for a bowel wash.The patient is hospitalized and fed via a nasogastric tube.
|