Model Number 20-9551TRAK2 |
Device Problem
Malposition of Device (2616)
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Patient Problems
Internal Organ Perforation (1987); Pneumothorax (2012)
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Event Date 11/01/2021 |
Event Type
Injury
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Manufacturer Narrative
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The actual complaint product was not returned for evaluation.The device history record for the reported lot number, 30148042, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.All information reasonably known as of (b)(6) 2022 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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Event Description
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It was reported via fda medwatch / fda user facility report #mw 5106141.The following information was provided: rn attempted to place a keofeed tube at bedside.X-ray confirmation for placement showed that the tube perforated the lung and caused a left sided pneumothorax.Which required a chest tube for treatment.
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Manufacturer Narrative
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All information reasonably known as of 21-mar-2022 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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