BEUDAMED
    FDA Adverse Event Summary report: N

    ZEISS ENT MICROSCOPE

    MDR report key: 33781 · Received May 31, 1996

    Report

    Report Number
    33781
    Date Received
    May 31, 1996
    Date of Event
    April 4, 1996
    Report Date
    May 15, 1996
    Manufacturer
    CARL ZEISS, INC.
    Product Code
    EPT
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TWO DEGREE BURN OF EAR AURICLE APPROX 5M X 2M. NOTED AT POST OP VISIT 4/10. MD FEELS OCCURRED USING ENT MICROSOCPE. EAR SPECULUM HEATED CAUSING BURN ALTHOUGH SKIN INTEGRITY AFTER CASE NOTED INTACT. REDNESS AND BLISTERING NOTED NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZEISS ENT MICROSCOPE MICROSCOPE EPT CARL ZEISS, INC. OPMI - ISH

    Patients

    Seq Age Sex Outcome Treatment
    1 20 MO