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Catalog Number SP-101 |
Device Problem
Biocompatibility (2886)
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Patient Problems
Hypersensitivity/Allergic reaction (1907); Rash (2033)
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Event Date 03/17/2021 |
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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Physician used venaseal to treat the patient¿s great saphenous vein (gsv).Ifu was followed and the vein is reported to have closed.It is reported 2 days post procedure the patient had what looked like a hypersensitivity reaction to the glue in the form of a rash which started on the chest, spread went down to the hands and onto both legs.The patient was prescribed prednisone, antihistamine, and anti-inflammatory medications.No additional treatment was required.
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Manufacturer Narrative
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Image review: six post-operative photographs of different parts of the patient¿s body exhibit red splotchy ¿hives¿ were received for analysis.The first three images are of the patient¿s left leg that exhibit red splotchy ¿hives¿.The fourth image is of the patient¿s inner thigh and exhibits red splotchy ¿hives¿.The fifth image is of the patient¿s chest and exhibits red splotchy ¿hives¿.The sixth image is of the patient¿s right palm and exhibits red splotchy ¿hives¿.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Additional information: the patient was prescribed nsaid¿s.There¿s been a full resolution after 1 week and the steroids have been stopped.The patient has said her legs feel amazing now and she¿s delighted with the result.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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