BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRYOSUCCESS

    MDR report key: 8440919 · Received March 21, 2019

    Report

    Report Number
    3008252257-2019-00001
    Event Type
    Malfunction
    Date Received
    March 21, 2019
    Date of Event
    January 24, 2019
    Report Date
    January 25, 2019
    Manufacturer
    NEW MEDICAL TECHNOLOGIES GMBH
    Product Code
    GEH
    PMA / PMN Number
    K0901721
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING THE TREATMENT OF A CONDYLOMA THE TIP DETACHED. PATIENT WAS SLIGHTLY HURT, SOME DROPS OF BLOOD WERE VISIBLE, THEY DISAPPEARED AFTER COMPRESSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234788 CRYOSUCCESS GENERAL CRYOSURGICAL SYSTEM, CRYOGEN GAS, MECHANICAL GEH NEW MEDICAL TECHNOLOGIES GMBH TIP 1 MM N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR