|
Catalog Number SP-101 |
Device Problem
Biocompatibility (2886)
|
Patient Problems
Erythema (1840); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930)
|
Event Date 07/11/2022 |
Event Type
Injury
|
Event Description
|
During procedure (april 2022), venaseal occluding device was implanted in the great saphenous vein (gsv).The vein effectively closed.Ifu was followed.A guidewire was used for the placing of the catheter.After the operation, the patient was examined the next day and there was no pruritus, etc.Loxonin (60) 3t3x for one week, and antibiotic flomox for 3 days were used.A month later, the patient had scheduled an outpatient visit in order to check the therapeutic effect through an echography, but he/she was too busy so did not visit the hospital.It was reported that the patient visited the hospital three months after the operation, there was redness.There was pain when pressed, and there was also a suspicion of infection, steroid 5mg and antibiotics are being prescribed.When hearing about it, pruritus had started immediately after operation, and redness also had started immediately after the operation.
|
|
Manufacturer Narrative
|
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.
|
|
Manufacturer Narrative
|
Image analysis two image files were returned for review: both images show redness along the venaseal treated segment with possible infection consistent with the reported event.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.
|
|
Search Alerts/Recalls
|
|
|