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.A root cause could not be determined.All information reasonably known as of (b)(6) 2024 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 reported event but is relaying the information provided by the user facility where the incident occurred.This product incident is documented in the avanos medical complaint database and identified as complaint comp (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 not returned.
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It was reported, the ¿two connector gastro tubing was replaced in (b)(6) 2023 due to two years of use.¿ patient began noting abdominal pain in (b)(6) 2023.In (b)(6) 2023, it was discovered that the ¿mic balloon collapsed and partially got into the tract; corrected via outpatient surgery by physician.¿ patient experienced acute abdominal pain when mic balloon collapsed.Movement of tube made pain worse.Stoma was red, oozing and very tender.Patient was prescribed bactrim twice a day (bid) for ten days.
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