It was reported via fda maude adverse event report mw18386277, on (b)(6) 2023: abdominal x-ray demonstrating massive pneumoperitoneum.Peritoneal drain placed at the bedside.On (b)(6) 2023: down trending platelet count.Exploratory laparotomy with creation of ostomy and mucus fistula.Generalized dusky bowel but no necrosis; on (b)(6) 2023: nitric oxide started.On (b)(6) 2023: hypotension requiring dopamine end fluid boluses.Severe acidosis noted.On (b)(6) 2023: laparotomy, ostomy takedown with temporary abdominal closure via silo.Continues on dopamine, dobutamine and epinephrine for blood pressure support.On (b)(6) 2023: silo removed, nec [necrosis] noted with 10 cm of ileum resected.
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H6: health effect - clinical code: appropriate term / code not available; pneumoperitoneum, down trending platelet count, acidosis, dusky bowel.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 12 feb 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: (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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