BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EYEMAG LIGHT II

    MDR report key: 7895708 · Received September 20, 2018

    Report

    Report Number
    9615010-2018-00013
    Event Type
    Injury
    Date Received
    September 20, 2018
    Date of Event
    August 3, 2018
    Report Date
    August 23, 2018
    Manufacturer
    CARL ZEISS MEDITEC AG (OBERKOCHEN)
    Product Code
    KYT
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, THE BATTERY PACK OF THE EYEMAG LIGHT II WORN BY A DOCTOR BECAME HOT AND BURNED HIM ON HIS ABDOMEN AREA. IT WAS REPORTED THAT THE BURN WAS 15MM X 7MM, HAD A FLUID FILLED BLISTER, AND WAS ACCOMPANIED BY REDNESS AND SORENESS. THE DOCTOR DID NOT SEEK ANY MEDICAL ATTENTION. PHOTOS SUBMITTED BY THE USER FACILITY SHOWED A DARK SCAR ON THE DOCTOR'S SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737320 EYEMAG LIGHT II LIGHT, EXAMINATION, MEDICAL, BATTERY POWERED KYT CARL ZEISS MEDITEC AG (OBERKOCHEN) N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other