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Device Problem
Patient-Device Incompatibility (2682)
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Patient Problems
Hypersensitivity/Allergic reaction (1907); Inflammation (1932)
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Event Date 12/04/2020 |
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 occluding device during procedure to treat 41cm of the great saphenous vein (gsv).The lumen was flushed prior to use.Ifu was followed.A guide wire was used for the insertion of the catheter.The vein was closed.It was reported that three weeks post procedure, patient experience skin irritation or burn with irritation present.The event was treated with benadryl and medrol pack.The symptoms of hypersensitivity started 3 weeks post procedure.The hypersensitivity was on the right along the gsv that was treated.The patient has not had a follow up yet.The patient received the medication this week.No further injury reported.
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Search Alerts/Recalls
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