BEUDAMED
    FDA Adverse Event Other Summary report: N

    FIBEROPTIC LIGHT SOURCE

    MDR report key: 29612 · Received December 23, 1995

    Report

    Report Number
    29612
    Event Type
    Other
    Date Received
    December 23, 1995
    Date of Event
    October 17, 1995
    Report Date
    December 23, 1995
    Manufacturer
    NORDEX MEDICAL CORP.
    Product Code
    FCW
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A MILD BURN WAS NOTED ON ABDOMINAL AREA FOLLOWING OUTPATIENT SURGERY (LEEP PROCEDURE). PT WAS EXAMINED AND TREATED. SILVADENE CREAM APPLIED TOPICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIBEROPTIC LIGHT SOURCE FIBEROPTIC LIGHT SOURCE FCW NORDEX MEDICAL CORP. FO - 150

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other