BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLAR WAND CRYOTHERAPY SYSTEM

    MDR report key: 638210 · Received June 2, 2005

    Report

    Report Number
    2529592-2005-00001
    Event Type
    Injury
    Date Received
    June 2, 2005
    Date of Event
    April 1, 2005
    Report Date
    May 1, 2005
    Manufacturer
    CHEK-MED SYSTEMS, INC./MYCOSCIENCE. INC
    Product Code
    GEH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    EVENT DESC: THE PT WAS UNDERGOING AN EGD (ESOPHAGO-GASTRODUODENOSCOPY) FOR CRYOTHERAPY OF A GASTROINTESTINAL BLEED USING THE POLAR WANT DEVICE. THE PT HAD A DISTENDED ABDOMEN AND BECAME PULSELESS. THE PT REC'D CPR AND WAS ADMITTED TO THE ICU. THE PT WAS EXTUBATED AND DISCHARGED HOME A DAY OR TWO LATER AND IS CURRENTLY DOING OKAY. IT IS UNCERTAIN IF THE DEVICE CONTRIBUTED TO THIS EVENT HOWEVER THERE HAVE BEEN TWO OTHER INCIDENTS WITH THIS DEVICE IN APPROX THE LAST YEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLAR WAND CRYOTHERAPY SYSTEM CRYOSURGICAL UNIT AND ACCESSORIES GEH CHEK-MED SYSTEMS, INC./MYCOSCIENCE. INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| L| R