BEUDAMED
    FDA Adverse Event Injury Summary report: N

    N/A

    MDR report key: 5998103 · Received October 4, 2016

    Report

    Report Number
    3005182235-2016-00033
    Event Type
    Injury
    Date Received
    October 4, 2016
    Date of Event
    September 9, 2016
    Report Date
    November 17, 2016
    Manufacturer
    N/A
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE DEVICE INVOLVED WITH THIS EVENT(S) WAS RETURNED TO COMPASS HEALTH BRANDS ON 10/24/2016, AND EVALUATED ON 10/25/2016. UPON INSPECTION, THE DEVICE WAS FOUND TO HAVE BEEN OPENED, AND THE ROLE HAD BEEN SLIGHTLY CUT/USED. THE ROLE APPEARS TO BE NORMAL, WITH NOTHING VISUALLY WRONG/OUT OF NORMAL. OVERALL, THE CUSTOMER'S REPORTS OF THIS EVENT COULD NOT BE DUPLICATED FROM A REVIEW OF THE RETURNED DEVICE.

    Description of Event or Problem · 1

    END-USERS ARE GETTING BLISTERS FROM THE TAPE. THE OFFICE HAS HAD 4-5 CLIENTS GET RASHES AND BLISTERS FROM THE TAPE. THE END-USERS, THAT RANGE FROM FIRST-TIME USERS TO THOSE WHO HAVE BEEN TAPED FOR OVER A YEAR WITH THIS TAPE OR ANOTHER BRAND WITHOUT ANY REACTIONS, ARE BREAKING OUT (WITH RASHES/BLISTERS). THE END-USERS ARE REPORTED AS HAVING BEEN 24-60 YEARS OLD (MULTIPLE PATIENTS REPORTED), AND BOTH MALE AND FEMALE. THE SKIN OF THE END-USERS WERE REPORTED AS HAVING BEEN PREPPED BEFORE APPLICATION, WITHOUT ANY SKIN SENSITIVITY/ALLERGIES - THE TAPE WAS ALSO REPORTED AS HAVING BEEN USED ON THE USERS' SHOULDERS AND REMOVED IMMEDIATELY ONCE THE IRRITATION WAS DISCOVERED. NO SKIN IS REPORTED AS HAVING BEEN SHAVED OR HAVING ANY TOPICAL GELS/LOTIONS APPLIED BEFORE THE APPLICATION OF THE TAPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647272 N/A N/A KGX N/A N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other