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 05-mar-2019 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).
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It was reported that there was an ill smelling flow out of the stoma site for five days.The stoma has been treated with silver nitrate, and the patient was prescribed fusidic acid cream and pyostacine two tablets two times a day.The patient has been under duodopa treatment since (b)(6) 2018.Previously in (b)(6) 2018, the patient had inflammation at the stoma site that required antibiotics (orbenine 500mg).Also previously the patient experienced black marks on the compress, abdominal pain, and burns around the stoma, as well as fluid leakage from the stoma.The patient also received antibiotics and topical care creams for stoma care.Per additional information received 25-feb-2019, the patient had previously pulled out her tube during a shower.The tube was already set to be replaced due to the reported infection.
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