BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEGADYNE MEDICAL PRODUCTS, INC.

    MDR report key: 432460 · Received December 13, 2002

    Report

    Report Number
    432460
    Event Type
    Injury
    Date Received
    December 13, 2002
    Date of Event
    July 1, 2002
    Report Date
    December 4, 2002
    Manufacturer
    MEGADYNE MEDICAL PRODUCTS, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS ADMITTED TO HOSP FOR BILATERAL BREAST AUGMENTATION. DURING THE PROCEDURE THE PT SUSTAINED A ONE MILLIMETER BURN TO THE NIPPLE AREA FROM THE CAUTERY TIP. THE SURGICAL TEAM EXAMINED THE CAUTERY TIP. BELIEVED THERE WAS A BREAK IN THE INSULATION OF THE TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEGADYNE MEDICAL PRODUCTS, INC. CAUTERY TIP GEI MEGADYNE MEDICAL PRODUCTS, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention