Model Number VS-402 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abscess (1690); Reaction (2414); Patient Problem/Medical Problem (2688)
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Event Date 04/16/2019 |
Event Type
Injury
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Manufacturer Narrative
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Event date is approximate (reported that issue noted approximately 1 week prior to (b)(6) follow up).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 venaseal to successfully treat a 53cm segment of the left great saphenous vein (gsv).A separate procedure was previously performed on the right gsv the ifu was followed and the procedure was completed normally and no additional treatment was required.The patient did not have any pain during the procedure.The patient had a dvt check on (b)(6) 2019 which was negative.It was reported that the patient experienced a skin irritation or burn one week prior to the (b)(6) visit.On (b)(6) the patient presented with two red hardened areas which had abscessed on the left leg and one on the right leg.The abscess was drained and hardened over.
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Manufacturer Narrative
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This patient had 4 venaseal procedures over two weeks in january 2019.This reaction, as associated with both legs have been reported per procedure.A 23cm segment of the patient¿s right small saphenous vein (ssv) was treated and compression was applied.The tip of the venaseal was 5cm caudal to the sfj, the procedure was completed normally, and no additional treatment was required.A mild reaction was noted on one week post the dvt check.A steroid dose pak was prescribed.This was noted to be resolved 9 days post prescription of the steroid dose pak.The patient returned for follow-up visit one-month post resolution of mild reaction with the abscess.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Image review: one image was received from the customer.Per the image, there is evidence of redness and abscessed at the treated site.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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