Model Number UNKNOWN |
Device Problems
Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Perforation (2001); Skin Discoloration (2074); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
Injury
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Manufacturer Narrative
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H10: health effect - clinical code appropriate term / code not available: pneumoperitoneum; minimal bowel gas 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 09 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 21 cfr 803, 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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Event Description
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It was reported via fda maude adverse event report mw18386115, "on (b)(6) 2023 patient [pt] admitted for extreme prematurity (23 3/7 weeks) weighing 650 grams.On (b)(6) 2023 5 french orogastric tube in place for decompression.On (b)(6) 2023 pt remained nothing by mouth [npo].On (b)(6) 2023 orogastric tube [ogt] removed secondary to questionable tracheal perforation versus mediastinal air from difficult intubation at birth.On (b)(6) 2023, abdominal assessment dusky across lower abdomen, abdominal x-ray with minimal bowel gas, surgery consult.On (b)(6) 2023 1400 two view abdominal x-ray with interval development of pneumoperitoneum.On (b)(6) 2023, 1451 surgery consult and penrose drain placement.".
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Manufacturer Narrative
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All information reasonably known as of 26 mar 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.
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Search Alerts/Recalls
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