BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARVIEW UTERINE

    MDR report key: 2994296 · Received March 1, 2013

    Report

    Report Number
    MW5029245
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Date of Event
    February 26, 2013
    Report Date
    March 1, 2013
    Manufacturer
    MA CLINICAL INNOVATIONS
    Product Code
    LKF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CLEARVIEW UTERINE MA CLINICAL INNOVATIONS BALLOON DID NOT INFLATE DURING SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89458 CLEARVIEW UTERINE NONE LKF MA CLINICAL INNOVATIONS UM 201

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR