AVANOS MEDICAL INC. INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 20FR DILATOR; DH EF PERC PLACEMENT PRODUCTS
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Model Number 98432 |
Device Problem
Break (1069)
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Patient Problem
Pain (1994)
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Event Type
malfunction
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Manufacturer Narrative
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The sample is reported to be available, but has not yet been received by the manufacturer.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of 14 jul 2020 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.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 complaint database and identified as complaint (b)(4).
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Event Description
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It was reported that during placement of the anchors, the sutures broke.Another kit was opened to complete the procedure, and six sutures in total were placed.No injury to the patient, other than pain from the sutures.No further information provided.
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Event Description
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Per additional information received on 3 aug 2020, the patient is currently fine, and is "receiving treatment for his pathology".
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Manufacturer Narrative
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All information reasonably known as of 12 aug 2020 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 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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