BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLASTICS TRAY

    MDR report key: 399323 · Received June 5, 2002

    Report

    Report Number
    399323
    Event Type
    Malfunction
    Date Received
    June 5, 2002
    Date of Event
    May 30, 2002
    Report Date
    June 4, 2002
    Manufacturer
    MEDLINE INC
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    GA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PT PRESENTED FOR BILATERAL AUGMENTATION; DURING SURGERY THE BOVIE PENCIL BURNED PT'S LEFT NIPPLE IN TWO PLACES. THE PENCIL TIPS WERE REPLACED AND PROCEDURE COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLASTICS TRAY CENTRAL/PLASTICS SURGERY GEI MEDLINE INC * 02BD2651

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR