Avanos medical inc.Received a single report that referenced two different incidences, which were associated with separate units, involving the same patient.This is the first of two reports.Refer to 9611594-2020-00102 for the second report.It was reported that the "patient treated for percutaneous gastrostomy.Gastrostomy anchors initially set up without worries.Probe set up without worries.With the withdrawal of the introducer: fall of the anchors.New placement of anchors from a new kit from the same batch with immediate fall from another anchor.3rd attempt with new kit always from the same batch: no problem observed." it was also reported that the patient developed "early pneumoperitoneum in the immediate aftermath.Patient kept hospitalized under surveillance.Need to keep the nasogastric tube and the esogastric [esophagastric] tube in suction for 48 hours.After 2 days without food, the gastrostomy is loaded.No signs of peritoneal irritation or pneumoperitoneum were observed.Patient will be able to return to his home." additional information received 26-may-2020 indicated "the pneumoperitoneum occurred during the procedure and because of successive ruptures of the anchors.They kept the patient under surveillance for 48 hours and the pneumoperitoneum observed developed very well and the patient was able to return home and is doing well.".
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The device history record for lot 20016171 was reviewed and the product was produced according to product specifications.The actual complaint product was not returned for evaluation.Root cause could not be determined.All information reasonably known as of 17 jul 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 comp-ehc-20-00668.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.
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