BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENACURE NEVERTOUCH

    MDR report key: 3843603 · Received May 27, 2014

    Report

    Report Number
    1319211-2014-00067
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    May 10, 2014
    Report Date
    May 12, 2014
    Manufacturer
    ANGIODYNAMICS
    Product Code
    GEX
    PMA / PMN Number
    K031233
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE DISPOSABLE DEVICE WAS DISCARDED BY THE USER AND IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. AN INVESTIGATION INTO THE ROOT CAUSE OF THIS INCIDENT IS CURRENTLY IN PROGRESS. THE RESULTS OF THE DEVICE EVALUATION WILL BE SENT VIA A FOLLOW UP MEDWATCH. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE REPORTED LOT FOR ANY DEVIATIONS RELATED TO THE REPORTED DEFECT OF THE COMPLAINT. THE REVIEW CONFIRMS THAT THE LOTS MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED ON (B)(6) 2014, A FEMALE PT OF UNK AGE PRESENTED FOR AN ENDOVENOUS LASER PROCEDURE. AFTER THE TREATING PHYSICIAN HAD INSERTED THE CATHETER, THE PT FELT ACHY AND HER SKIN TURNED RED. THE PT WAS MONITORED, AND AFTER A FEW MINUTES OF THE REPORTED COMPLAINT, THE PT WAS REPORTED AS FEELING FINE. THE PT'S LEG HAD BEEN PREPPED WITH HIBACLENS AND HAD NO OTHER TOPICAL OR INJECTED DRUGS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO REPORTS OF COMPLICATIONS OR DEVICE MALFUNCTIONS. THERE WAS NO REPORT OF PERMANENT HARM OR INJURY TO THE PT DUE TO THE EVENT. IT WAS REPORTED THE DISPOSABLE DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION, AS IT WAS DISPOSED OF BY THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311767 VENACURE NEVERTOUCH ENDOVENOUS LASER TREATMENT FIBER GEX ANGIODYNAMICS 4714710

    Patients

    Seq Age Sex Outcome Treatment
    1