BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICEPEARL CRYOABLATION NEEDLE

    MDR report key: 8110895 · Received November 27, 2018

    Report

    Report Number
    MW5081668
    Event Type
    Injury
    Date Received
    November 27, 2018
    Date of Event
    November 21, 2018
    Report Date
    November 26, 2018
    Manufacturer
    GALIL MEDICAL INC.
    Product Code
    GEH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE SHEATHING ABOVE THE CRYO NEEDLE POPPED REQUIRING THE PROCEDURE TO BE STOPPED AND A NEW NEEDLE OBTAINED TO CONTINUE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    946702 ICEPEARL CRYOABLATION NEEDLE UNIT, CRYOSURGICAL, ACCESSORIES GEH GALIL MEDICAL INC. FPRPR3601

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention