BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EYEMAX2

    MDR report key: 11457394 · Received March 10, 2021

    Report

    Report Number
    1000117260-2021-00002
    Event Type
    Malfunction
    Date Received
    March 10, 2021
    Report Date
    March 9, 2021
    Manufacturer
    MAXTEC, LLC
    Product Code
    FOK
    UDI-DI
    00817770022039
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MAXTEC'S COMPLETE COMPLAINT DATABASE WAS SEARCHED. THE TOTAL AVAILABLE COMPLAINTS DATE RANGE WAS FROM (B)(6) 2017 - (B)(6) 2021. THERE WERE ZERO (0) COMPLAINTS RELATING TO A "SLIPPERY" EYEMAX2 REGULAR (R300P01-002). THE MAUDE DATABASE WAS REVIEWED FROM (B)(6) 2019 TO (B)(6) 2021, PRODUCT CODE FOK: THERE WERE A TOTAL OF 4 REPORTABLE EVENTS, 3 OUT OF THE 4 EVENTS INVOLVED MASK "SLIPPAGE", 0 OUT OF THE 4 EVENTS INVOLVED THE R300P01-002 EYEMAX2, 1 OUT OF THE 4 EVENTS INVOLVED AN EYEMAX2. MAXTEC WILL CONDUCT A PHYSICAL EVALUATION WHEN THE EYEMAX2 IN QUESTION IS OBTAINED. THE ROOT CAUSE IS UNKNOWN.

    Description of Event or Problem · 1

    AS DESCRIBED BY THE CUSTOMER: FIRST OF ALL, WE RECEIVED A CUSTOMER COMPLAINT ABOUT YOUR EYEMAX PRODUCT (REGULAR). OUR CUSTOMERS FIND THAT THEIR EYEMAX (BATCH NUMBER: 044284-1) APPEARED TO BE MORE SLIPPERY THAN BEFORE. THEY NEED TO REPOSITION THEM REGULARLY AND EVEN TO MAKE IT HOLD BY OTHER MEANS. IT SEEMS TO BE CAUSED BY THE NEW MATERIAL. THEY ARE AFRAID FOR THE SAFETY OF THE BABY WITH THE RISK OF EYE BURNS. IT SEEMS THAT THEY ARE THINKING ABOUT REPORTING A VIGILANCE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354564 EYEMAX2 PHOTOTHERAPY MASK FOK MAXTEC, LLC R300P01-002 044284-1 00817770022039

    Patients

    Seq Age Sex Outcome Treatment
    1 Other