The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.All information reasonably known as of (b)(6)2023 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.H3 other text : device no returned.
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It was reported the patient's partner was able to pull most of the catheter out without pain and he "believes the last part of the catheter is stuck and painful when pulling." the caller was advised to attempt a warm compress for 30 minutes and try again."the patient went to the hospital, where the anesthesiologist was unable to remove it in the emergency room (er) procedure room.They were waiting for general surgeon to come remove it." additional information received (b)(6)2023 noted the patient spent 7-hours in er."the anesthesiologist couldn't remove, they called [general] surgeon, who also encountered challenge.[the clinicians were] going to take patient to surgery, but surgeon tried one more time and pulled hard, and catheter came out.The patient is doing okay.
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