BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EYEMAX21

    MDR report key: 11639394 · Received April 8, 2021

    Report

    Report Number
    1000117260-2021-00003
    Event Type
    Malfunction
    Date Received
    April 8, 2021
    Date of Event
    November 16, 2018
    Report Date
    April 8, 2021
    Manufacturer
    MAXTEC
    Product Code
    FOK
    PMA / PMN Number
    510 EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    MAXTEC CONTACTED THE END-USER MULTIPLE TIMES VIA EMAIL FOR FURTHER DETAILS OF COMPLAINT TO CONDUCT FURTHER INVESTIGATION. NO RESPONSE RECEIVED AS OF (B)(6) 2018. THE COMPLAINT WAS CLOSED ON (B)(6) 2019, AND NO FURTHER ACTION WAS TAKEN. AN ADVERSE EVENT WAS NOT REPORTED IN 2018, DUE TO MANAGEMENT OVERSIGHT. A REVIEW OF ALL EYEMAX COMPLAINTS CONDUCTED ON (B)(6) REVEALED THE COMPLAINT AND MANAGEMENT WAS MADE AWARE ON MARCH 9TH. THE DEVICE IS UNAVAILABLE FOR INVESTIGATION. MAXTEC WAS UNABLE TO REACH THE END USER. MAXTEC IS UNABLE TO CONFIRM THE EYEMAX MODEL IN QUESTION.

    Description of Event or Problem · 1

    END USER ADVISED THAT THE EYEMAX2 HAS DESIGN PROBLEMS THAT MAY POSE A RISK FOR SUFFOCATION FOR THE BABY. THE FIXATION MECHANISM OF THIS MASK (BASED ON ELASTOMER BANDS) IS NOT SECURED ENOUGH, SO THE MASK CAN SLIDE IF THE BABY ROLLS OR TRIES TO PULL IT OFF. THE MASK DOES NOT COMPLETELY ADJUST TO THE FACIAL FEATURES EITHER AND THIS IS SPECIAL RELEVANCE ON THE NOSE REGION. AS A CONSEQUENCE OF THE ABOVE, THE MASK SLIDES ONTO THE NOSE OF THE BABY IMPEDING ITS NORMAL BREATHING. WE SAW THAT HAPPENING MULTIPLE TIMES DURING THE 8TH THERAPY THAT OUR DAUGHTER WENT THROUGH. IF WE WERE NOT FULLY FOCUSED ON HER, SHE COULD HAVE SUFFOCATED. SUGGESTION OFFERED: IN ORDER FOR THE MASK TO BETTER ADJUST TO THE NOSE AREA, COULD YOU NOT USE A FIXTURE WITH THE SHAPE OF THE NOSE (SIMILAR TO NORMAL GLASSES) SO THE MASK CANNOT SLIDE DOWN? ANOTHER POSSIBILITY WOULD BE A MASK OR BETTER SAID GLASSES SIMILAR TO THE ONES THAT SWIMMERS USE. THEY WOULD ADAPT TO THE EYE'S SHAPE, COULD BE TIGHTENED BY A BAND. THEY WOULD ALSO LEAVE MORE FACIAL SURFACE EXPOSED TO THE TREATMENT AND THE MATERIAL COULD BE SIMILAR TO THE ONE IN GLASSES USED FOR WORK IN LASER LABS. I AM AWARE THAT THERE ARE OTHER SIZES AVAILABLE BUT THE PROBLEM IS THAT ALTHOUGH THE SMALL SIZE WAS PERFECT FOR HER EYES AND FACE, THE BANDS WERE NOT LONG ENOUGH FOR HER HEAD CIRCUMFERENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530285 EYEMAX21 PHOTOTHERAPY MASK FOK MAXTEC UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other