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Catalog Number VS-403 |
Device Problem
Biocompatibility (2886)
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Patient Problems
Itching Sensation (1943); Burning Sensation (2146)
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Event Date 03/09/2023 |
Event Type
Injury
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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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Event Description
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A patient was treated with venaseal in gsv great saphenous vein the on the (b)(6) 2023.The ifu was followed, all procedures are the same as ifu, not different from ifu.The catheter lumen was not flushed prior to use.It was reported afterwards the patient has generalized itching and burning.Just one leg was treated, but the reaction was present to the whole body.Allegra was prescribed.Symptoms disappeared while taking the drug but reappeared when stopped taking it.Thepatient had an emergency medical consultation.Examination by the attending physician today, the patient refused oral steroids, and requested removal.Surgery is scheduled for april 6.Currently, the patient is prescribed/orally administered antihistamines, and symptoms are improving.Currently, the patient is prescribed/orally administered antihistamines, and symptoms are improving.An allergy test (dlst test) will be conducted next week (march 16).Prescription medication, oral steroids are scheduled to be prescribed at the medical examination on march 16.Based on the results of the allergy test, extraction surgery is reconsidered.Update reported thay condition is getting better from the steroid prescription and no longer scheduled for removal surgery which was originally scheduled for april 6.Re-examination scheduled approximately 1 months¿ time.Just one leg was treated, but the reaction was present to the whole body.All procedures were per ifu, not different from ifu.
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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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