BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE CYTOLOGY BRUSH

    MDR report key: 97607 · Received June 12, 1997

    Report

    Report Number
    MW1011473
    Event Type
    Injury
    Date Received
    June 12, 1997
    Date of Event
    April 30, 1997
    Report Date
    June 11, 1997
    Manufacturer
    MEDICAL INNOVATIONS CORP.
    Product Code
    BTG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PLASTIC TIP OF DISPOSABLE CYTOLOGY BRUSH FELL OFF DURING BRONCHOSCOPY. PT REQUIRED SECOND BRONCHOSCOPY TO REMOVE TIP FROM PT'S LUNG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE CYTOLOGY BRUSH DISPOSABLE CYTOLOGY BRUSH BTG MEDICAL INNOVATIONS CORP. * 6112-7902

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention