BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SANARUS VISICA 2 TREATMENT SYSTEM

    MDR report key: 885938 · Received July 26, 2007

    Report

    Report Number
    3003515897-2007-00008
    Event Type
    Injury
    Date Received
    July 26, 2007
    Date of Event
    May 30, 2007
    Report Date
    July 26, 2007
    Manufacturer
    SANARUS MEDICAL, INC.
    Product Code
    GEH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT RECORDS WERE REVIEWED FOR THIS LOT OF MATERIAL AND STERILIZATION DOSAGE WAS CONFIRMED.

    Description of Event or Problem · 1

    A PATIENT HAD CRYOABLATION OF HER FIBROADENOMA USING THE VISICA 2 TREATMENT SYSTEM IN 2007. WHEN THE PATIENT RETURNED TO THE DOCTOR FOR FOLLOW-UP APPROX ONE AND A HALF MONTHS LATER,, SHE PRESENTED WITH REDNESS AND SWELLING OF HER BREAST AND WAS DIAGNOSED WITH CELLULITIS. SHE WAS STARTED ON ORAL ANTIBIOTICS. THE PATIENT RETURNED TO THE DOCTOR FOR FOLLOW-UP SIX DAYS LATER. DURING THE VISIT, THE DOCTOR EVALUATED THE AREA AGAIN AND DIAGNOSED THE PATIENT WITH AN INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SANARUS VISICA 2 TREATMENT SYSTEM VISICA 2 GEH SANARUS MEDICAL, INC. VP0600 V2070502

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention