BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROMANIPULATOR

    MDR report key: 33754 · Received May 7, 1996

    Report

    Report Number
    33754
    Event Type
    Injury
    Date Received
    May 7, 1996
    Date of Event
    April 12, 1996
    Report Date
    May 3, 1996
    Manufacturer
    HERAEUS SURGICAL, INC.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT SUSTAINED 8MM, THIRD DEGREE BURN TO RIGHT UPPER LIP DURING LASER PROCEDURE. IT APPEARS THAT THE SET SCREW HAD LOOSENED ALLOWING THE MIRROR TO SPIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROMANIPULATOR LASER GEX HERAEUS SURGICAL, INC. LS-11

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Other| R