BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ER

    MDR report key: 6698903 · Received July 10, 2017

    Report

    Report Number
    1119903-2017-00001
    Event Type
    Injury
    Date Received
    July 10, 2017
    Date of Event
    April 12, 2017
    Report Date
    April 12, 2017
    Manufacturer
    BTE TECHNOLOGIES
    Product Code
    IKK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MAY 11, 2017 - THE FINAL REPORT WILL BE SUBMITTED TO THE FDA BY JULY 12, 2017. IT IS EXPECTED THAT BY THIS TIME THE RELEVANT COMPONENTS WILL BE RETURNED TO BTE FROM THE CUSTOMER SITE AND THE INVESTIGATION COMPLETED. NOVEMBER 13, 2020 - THE INITIAL REPORT ORIGINALLY SUBMITTED ON MAY 11, 2017 WAS RESUBMITTED IN NOVEMBER 2020 FOLLOWING FDA NOTIFICATION THAT THE INITIAL REPORT IS NOT IN THE FDA RECORDS. THE FINAL FOLLOW-UP REPORT SUBMITTED ON JULY 10, 2017 IS ATTACHED TO SHOW COMPLETE RECORDS EVEN THOUGH THERE ARE NO INDICATIONS THAT THE FINAL REPORT IS MISSING.

    Description of Event or Problem · 1

    WHILE STRUGGLING TO REMOVE D-HANDLE DURING UTM CALIBRATION, OPERATOR HIT HERSELF IN THE FACE WHICH RESULTED IN VISIBLE SWELLING AROUND THE NOSE. THE OPERATOR WAS EXAMINED AT AN URGENT CARE FACILITY AND NOTIFIED THE CLINIC THAT THE NOSE WAS NOT BROKEN BUT SHE NEEDED TO TAKE A FEW DAYS OFF. THE INCIDENT OCCURRED DURING EQUIPMENT CALIBRATION (PRODUCT SETUP PRIOR TO TESTING). NO CLIENTS/PATIENTS WERE INVOLVED AND ONLY THE OPERATOR HAD BEEN AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480454 ER ER IKK BTE TECHNOLOGIES ER

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female Other