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Device Problem
Biocompatibility (2886)
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Patient Problems
Hypersensitivity/Allergic reaction (1907); Pain (1994); Insufficient Information (4580)
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Event Date 09/06/2021 |
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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Patient caller has reported following treatment of the left great saphenous vein (gsv) with venaseal a first lump appeared and 2 more months after the first one 2 other ones came out together with a reddish skin reaction.The patient has reported their surgeon was absolutely surprised.The patient reports that apparently her body reacted upon the glue used to block the vein.The patient has queried what is the protocol facing this very unpleasant problem to eliminate them.The patient has reported to have started feeling pain also.The ifu was followed.No issue with the location of catheter tip prior to initial delivery of adhesive.The catheter tip was 5cm caudal to sfj.No compression of gsv.Patient reported the event to the physician and was prescribed chlorpheniramine 4mg tid x 4 days, follow by chlorpheniramine 4mg bid x 6 days was prescribed, but instructions were not followed due to countermand by patient¿s ophthalmologist who was concern for potential glaucoma risk.Naproxen 500mg bid x 7 days + celestone im x 1 dose was prescribed instead.Patient showed improvement after treatment.The physician was again contacted by patient with worsening of symptoms in her calf.The physician spoke to the patient¿s ophthalmologist and reached an agreement for chlorpheniramine 4mg tid x 4 days, follow by chlorpheniramine 4mg bid x 6 days.The issue is still present, although, much improved after this treatment.
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Manufacturer Narrative
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Image review: three images were provided in the article for review.Image 1: pre-operative image demonstrating the patient¿s erythematous lesion of the mid-thigh.Image 2: ultrasound image demonstrating a subcutaneous heterogeneous hypoechoic collection, underlying the erythematous lesion of the patient¿s thigh.Image 3: histology image from the excised tissue (haemotoxylin and eosin; 200_ magnification).Multinucleated giant cells can be seen surrounding clear, non-refractile glue, which are in turn surrounded by plasma cells and lymphocytes 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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