BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEOTECH

    MDR report key: 7966413 · Received October 15, 2018

    Report

    Report Number
    2025917-2018-00112
    Event Type
    Injury
    Date Received
    October 15, 2018
    Report Date
    October 15, 2018
    Manufacturer
    NEOTECH PRODUCTS LLC
    Product Code
    FOK
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED AND NO EVALUATION IS POSSIBLE ON THE ACTUAL DEVICE. ONE DEVICE FROM THE SAME LOT NUMBER WAS RETURNED BY CUSTOMER. PER OUR PRODUCT ENGINEER'S REPORT, THERE IS NO ISSUE WITH THE DESIGN OF PRODUCT WHICH IS INTENDED TO PROTECT EYES DURING PHOTOTHERAPY SESSION. DEVICE AFFIX TO THE PATIENT HEAD WITH TWO TABS TO COVER THE EYES. THE TABS ARE COMPOSED OF MEDICAL GRADE HYDROCOLLOID ADHESIVE AT ONE SIDE TO CONTACT TO SKIN AND THE VELCRO HOOKS AT THE OTHER SIDE TO ATTACH TO NEOSHADE WHICH IS MADE FROM VELCRO HOOKS ADAPTIVE FABRIC. THE VELCRO HOOK TYPE IS JUST STRONG ENOUGH TO SECURE NEOSHADE ON THE PATIENT'S EYES DURING A FULL PHOTOTHERAPY SESSION. IT SEEMS THAT THE SKIN BREAKDOWN WAS CAUSED BY NOT FOLLOWING THE DIRECTION OF USE FOR REMOVING THE PRODUCT. THIS DEVICE HAS BEEN IN THE MARKET FOR ABOUT TWENTY YEARS AND COMPLY WITH BIO-COMPATIBILITY REQUIREMENTS ((B)(4)). NEOSHADES ARE ALSO AVAILABLE WITH HEAD STRAP BAND WHICH WAS DESIGNED TO KEEP THE DEVICE SECURE ON PATIENTS WITH SENSITIVE SKIN. THIS COMPLAINT WILL BE MONITORED FOR TRENDING PURPOSES AND IS ADDED TO THE RELATED LOGS AND CHARTS.

    Description of Event or Problem · 1

    SKIN BEAKDOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    806743 NEOTECH NEOSHADES WITH TABS FOK NEOTECH PRODUCTS LLC N720 2017-0952

    Patients

    Seq Age Sex Outcome Treatment
    1 4 DA Other