BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SANARUS VISICA TREATMENT SYSTEM

    MDR report key: 520148 · Received April 7, 2004

    Report

    Report Number
    3003515897-2004-00003
    Event Type
    Injury
    Date Received
    April 7, 2004
    Date of Event
    March 10, 2004
    Report Date
    April 7, 2004
    Manufacturer
    SANARUS MEDICAL, INC.
    Product Code
    GEH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A PATIENT WAS TREATED WITH THE VISICA SYSTEM FOR A FIBROADENOMA OF APPROX 0.7 XM IN SIZE. THE PROCEDURE WAS STARTED AND ABOUT 2 MINUTES INTO THE PROCEDURE, THE PHYSICIAN BECAME CONCERNED THAT THE DISTAL END OF THE PROBE WAS TOO NEAR THE PATIENT'S SKIN. THE SKIN RETRACTED AND APPEARED RED. THE PHYSICIAN ATTEMPTED TO INJECT SALINE TO SEPARATE THE SKIN FROM THE ICEBALL, BUT COULD NOT SUCCESSFULLY DO SO. HE ABANDONED THE SECOND FREEZE CYCLE. THE PATIENT'S SKIN APPEARED TO BE FINE WITHIN 10 MINUTES OF THE PROCEDURE'S END. THE PHYSICIAN SAW THE PATIENT SHORTLY AFTER THE PROCEDURE AND OBSERVED SOME ECCHYMOSIS THAT IS CONSISENT WITH THE PROCEDURE AND "LIGHT BROWN PATCH" OF ABOUT 1.2 X 0.5 CM IN THE AREA THAT WAS AFFECTED BY THE DISTAL END OF THE PROBE. HE INSTRUCTED THE PATIENT TO APPLY COCOA BUTTER CREAM TO THE AREA. THE PHYSICIAN REPORTED 17 DAYS LATER THAT THE PATIENT WAS DOING WELL BUT HAD A SMALL AREA OF DEPIGMENTED SKIN MEASURING ABOUT 1.0 X 0.5 CM IN SIZE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SANARUS VISICA TREATMENT SYSTEM CRYOABLATION SYSTEM GEH SANARUS MEDICAL, INC. VP0500 V040202

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention