Catalog Number UNK-PLY-VENASEAL |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Itching Sensation (1943); Pain (1994); Reaction (2414)
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Event Date 11/30/2017 |
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 used the venaseal to treat 2 segments(approximately 30cm) of the great saphenous vein(gsv) in both legs.The ifu was followed.Approx.3-3.5ml of cyanoacrylate (glue) was reported to have been used.It was reported the patient presented with painful red itchy skin at the treatment site, 2 weeks post procedure.The patient was treated ((b)(6) 2017), with prednisone (steroid) for 4 days.The patient¿s condition is reported to be improving.
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Manufacturer Narrative
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Evaluation summary: no components from the venaseal closure system kit was received for evaluation.No sonographic images were received for evaluation.Two photographic images of the patient¿s symptoms were received for evaluation.The images are of the patient¿s treated legs several days after treatment.Splotchy redness of the skin is noted on the treated legs.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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