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Catalog Number VS-404 |
Device Problem
Biocompatibility (2886)
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Patient Problem
Hypersensitivity/Allergic reaction (1907)
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Event Date 11/01/2022 |
Event Type
Injury
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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A patient was treated with venaseal in an unknown vessel.The patient noticed a rash on legs/body approximately 12 post procedure.The patient went to walk in clinic on 17 days post procedure where prednisone, famotidine, and zyrtec were prescribed.Patient did not start prednisone until the 6th d/t the late hour of the day.Patient saw a physician and the patient is currently still on prednisone taper and will do 20 mgs then going to 10 mg for 3 days before stopping.Patient went to the er approximately 22 days post procedure with lip swelling and facial swelling and was given epinephrine 0.3 mg and sent home with one.Patient does not have any trouble breathing or swallowing.There was no challenges or deviations related location of catheter tip prior to initial delivery of adhesive, catheter tip 5cm caudal to sfj or compression of gsv.There are no ultrasound images/photographs that depict this condition.Patient says it is all clear now.Left gsv ankle to distal thigh was treated.Only one leg is treated.No further patient injury reported for this event.
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Manufacturer Narrative
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Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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