The actual complaint product was not returned for evaluation.Root cause could not be determined.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of (b)(6) 2021 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 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 by the patient to the distributor that on (b)(6) 2021 the patient's peg jejunstomy tube had migrated four inches out, and in addition, the patient had been experiencing a stoma site infection for three days and has been on antibiotics.The patient reported that there was now pus coming from the stoma site, but it was not bleeding or painful.The patient reported that they had discontinued use of the duodopa pump, but had oral medication (carbidopa/levodopa) to take instead.The patient had determined that he will go to the emergency room to be seen regarding the stoma site infection.Per additional information received 23 jun 2021, the patient was taking cefadroxil antibiotic for the stoma infection starting on (b)(6) 2021.When the patient was seen at the er on (b)(6) 2021, he was prescribed a stronger oral antibiotic, sulfameth/trimethoprim, for the infection, and continues to take at this time.Per additional information provided by the distributor on 28 jun 2021, the patient stated they went to (b)(6) hospital and medical center at (b)(6).
|