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Catalog Number SP-101 |
Device Problem
Biocompatibility (2886)
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Patient Problems
Local Reaction (2035); Swelling/ Edema (4577)
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Event Date 10/05/2021 |
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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The physician attempted to use a venaseal closure system to treat the great saphenous vein of a patient.The vein is reported to have closed.The procedure was completed as normal.3 weeks post procedure a rash occurred in the treatment region after using venaseal.The rash at the treatment site healed immediately with the drug, but the patient had swelling in the pharynx.Patient was hospitalized.Swelling in the pharynx is related to allergies and stress so physician was concerned that venaseal adhesive was also considered to be a cause.Patient status unknown.
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Manufacturer Narrative
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Additional information.It was reported that approximately 3 weeks post procedure, swelling and itching occurred in the treated region.Following day start of reaction, swelling occurred in the pharynx region.Ifu was followed.About 0.8cc of glue was used during procedure.One leg was treated.As it was a case of recurrence of the lower leg after stripping, puncture was performed from the peripheral region of the left foot, and the catheter tip reached the knee region.Ebastine provided for patients rash.Drip infusion and ebastine was prescribed for swelling in pharynx.Same day of prescription, the patient experienced swelling in the root of the tongue and pharynx, so patient visited the nearby otolaryngology department and was hospitalized in a second hospital.Swelling had subsided the following day, the patient was discharged from the hospital two days later.Swelling in the lower leg seemed to remain.Patient currently has no problem.No further injury reported.Implant date provided and event date updated.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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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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