BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WA1000B CRYOSURGICAL CONSOLE SYSTEM & CRYOTIP

    MDR report key: 1860296 · Received September 23, 2010

    Report

    Report Number
    1216677-2010-00005
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    August 26, 2010
    Report Date
    September 1, 2010
    Manufacturer
    WALLACH SURGICAL DEVICES
    Product Code
    GEH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CRYOSURGICAL CONSOLE SYSTEM WITH CRYOTIP WAS BEING USED ON A MALE PT FOR THE REMOVAL OF GENITAL WARTS. THE TIP DISENGAGED AFTER A LOUD BANG AND HIT THE PT IN THE SCROTUM. THERE WAS A LACERATION AND BLEEDING. AFTER SEEING THE PT AGAIN THE NEXT DAY, IT APPEARED TO BE HEALING WITH NO BRUISING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WA1000B CRYOSURGICAL CONSOLE SYSTEM & CRYOTIP NONE GEH WALLACH SURGICAL DEVICES LL-100

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention