BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SANARUS VISICA TREATMENT SYSTEM

    MDR report key: 500684 · Received December 10, 2003

    Report

    Report Number
    3003515897-2003-00024
    Event Type
    Injury
    Date Received
    December 10, 2003
    Date of Event
    November 14, 2003
    Report Date
    December 10, 2003
    Manufacturer
    SANARUS MEDICAL, INC.
    Product Code
    GEH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN ATTEMPTED TREATMENT OF A 1.5 CM FIBROADENOMA USING THE VISICA TREATMENT SYSTEM. WHEN THE PHYSICIAN FELT THAT SHE HAD ADEQUATELY PLACED THE PROBE WITHIN THE FIBROADENOMA, SHE INITIATED THE FREEZE. WITHIN THE FIRST MINUTE, DR NOTICED FREEZING ON THE SKIN AT THE PROBE ENTRY SIDE. THE SALES REPRESENTATIVE PRESENT NOTICED THE FREEZING AREA OF THE PROBE WAS NOT INSERTED FAR ENOUGH INTO THE SKIN. THE FREEZE CYCLE WAS STOPPED AND THE PROBE WAS REMOVED. DR INJECTED SALINE AROUND THE SITE AND APPLIED A WARM COMPRESS. THE PATIENT WAS GIVEN ANTIBACTERIAL CREME TO APPLY TO THE AREA AND WAS SENT HOME. THE PATIENT WAS SEEN IN THE OFFICE IN 11/2003 AND WAS EXAMINED. THE PATIENT WAS REPORTED TO HAVE MINIMAL RESIDAL ERYTHEMA AND THE APPROXIMATELY 1 CM AREA OF AFFECTED TISSUE WAS NEARLY "CLEARED UP." THE PATIENT WAS INSTRUCTED TO CONTINUE APPLYING THE ANTIBACTERIAL CREME TO THE AREA. THE PHYSICIAN DID NOT ANTICIPATE THAT THE PATIENT WOULD HAVE A PERMANENT SCAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SANARUS VISICA TREATMENT SYSTEM CRYOABLATION SYSTEM GEH SANARUS MEDICAL, INC. VP0500 V031001

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention