Avanos medical received a single report that referenced four different incidences, which were associated with separate units, involving four different events.This is the first of four reports.Refer to 3011270181-2024-00004 for the second event.Refer to 3011270181-2024-00005 for the third event.Refer to 3011270181-2024-00006 for the fourth event.It was reported there was an event relating to gastric perforation in the patient who also had an avanos feeding tube.
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The actual complaint product was not returned for evaluation.A review of the device history record is in-progress.All information reasonably known as of 12-jan-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: the device was not returned.
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