Model Number UNKNOWN |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Unspecified Infection (1930)
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Event Type
Injury
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Manufacturer Narrative
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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 20-dec-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.
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Event Description
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Avanos medical received a single report that referenced nine different incidences, which were associated with separate units, involving nine different patients.This is the ninth of nine reports.Refer to 3011270181-2023-00141 for the first event.Refer to 3011270181-2023-00142 for the second event.Refer to 3011270181-2023-00143 for the third event.Refer to 3011270181-2023-00144 for the fourth event.Refer to 3011270181-2023-00145 for the fifth event.Refer to 3011270181-2023-00146 for the sixth event.Refer to 3011270181-2023-00148 for the eighth event.It was reported a neoconnect nasogastric tube was in use on a patient.The patient developed necrotizing enterocolitis (nec) or spontaneous intestinal perforation (sip).The cause of nec and sip are unknown at this time.Additional information has been requested.
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Event Description
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Additional information received 01-feb-2024 stating the user "facility's findings of their assessment of the infants affected by necrotizing fasciitis (nec) in their (b)(6) on (b)(6) 2024.The facility swabbed and cultured the ng (nasogastric) tubes and gastric/intestinal content of the infants affected, and conclusively found no evidence the cases of nec were caused by avanos' ng tubes." the patient had normal abdominal flora and no indications the ng tube was the cause of the nec.Additional information received 04-feb-2024 stated devices were placed (b)(6) 2023 and (b)(6) 2023.The patient had a sump drain placed (b)(6) 2023 and underwent an exploratory laparotomy on (b)(6) 2023.The patient underwent bedside placement of a penrose drain on (b)(6) 2023.
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Manufacturer Narrative
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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 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.
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Search Alerts/Recalls
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