BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOTECH

    MDR report key: 6147760 · Received December 6, 2016

    Report

    Report Number
    2025917-2016-00109
    Event Type
    Malfunction
    Date Received
    December 6, 2016
    Date of Event
    May 17, 2016
    Report Date
    November 23, 2016
    Manufacturer
    NEOTECH
    Product Code
    FOK
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED AND NO EVALUATION IS POSSIBLE ON THE ACTUAL DEVICE. IN OUR INVESTIGATION AND FOLLOW-UP WITH THE REPORTING FACILITY, THE REPORTER (B)(6) THE CLINICAL EFFECTIVENESS-DATA MANAGEMENT, STATED THAT IT WAS THE FIRST TIME THE NURSES HAD TRIED TO USE THE PRODUCT AS THEY HAD SOME SAMPLES. SHE ALSO COULD NOT SPEAK TO WHETHER THE DFU WAS REFERRED PRIOR TO USE OR NOT. THERE IS A GREAT PROBABILITY THAT THE NURSES DID NOT READ THE DIRECTION OF USE REGARDING PROPER ACTIVATION OF THE ADHESIVE BEFORE USE, OTHERWISE THE PART WOULD NOT COME OFF THE FACE. THIS LINE OF PRODUCT IS BIOCOMPATIBLE PER PBL REPORT# (B)(4). IT SEEMS THAT THE SKIN REDNESS WAS CAUSED BY NOT FOLLOWING THE DIRECTION OF USE FOR REMOVING THE PRODUCT. (B)(6) ALSO INFORMED US THAT THE BABY WAS NOT HARMED AND HAS BEEN DISCHARGED. THIS COMPLAINT WILL BE MONITORED FOR TRENDING PURPOSES AND IS ADDED TO THE RELATED LOGS AND CHARTS. DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    INSTABILITY OF MASK AND SKIN REDNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797518 NEOTECH NEOSHADES WITH TABS FOK NEOTECH N721

    Patients

    Seq Age Sex Outcome Treatment
    1 Other