VENA SEAL CLOSURE SYSTEM
Received Mar 3, 2016 · Event occurred Mar 27, 2015
Report 3011410703-2016-00002 · MDR key 5476092
Device
Generic name
Closure, Wound, Adhesive
Manufacturer
Sapheon/medtronicModel number
SP-101Catalog number
SP-101
Lot number
37621
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Reaction
- Reaction
Narrative
Additional Manufacturer Narrative
(B)(4). A CAPA HAS BEEN OPENED TO MANAGE THE ACTIONS RELATED TO REMEDIATION OF COMPLAINT FILES AND ANY REQUIRED MDR REPORTING. (B)(4).
Description of Event or Problem
IT WAS REPORTED THE PATIENT UNDERWENT VENASEAL TREATMENT OF LEFT LONG SAPHENOUS VEIN. NO PROBLEMS AT THE TIME OF THE PROCEDURE, BUT 11 DAYS LATER, PATIENT HAS CONTACTED THE DOCTOR COMPLAINING OF REDNESS ON THE SKIN, ITCH AND SOME PAIN. THE SAMPLE WAS NOT AVAILABLE FOR RETURN BY THE END USER. THE MILD INFLAMMATION RESPONDED WELL TO ORAL AND TOPICAL ANTI-INFLAMMATORY WHICH IS CONSISTENT WITH NON-SPECIFIC MILD INFLAMMATION OF THE CUTANEOUS AND SUBCUTANEOUS TISSUE.