BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAYSY

    MDR report key: 9205972 · Received October 17, 2019

    Report

    Report Number
    3011197658-2019-00001
    Event Type
    Injury
    Date Received
    October 17, 2019
    Date of Event
    August 27, 2019
    Report Date
    September 24, 2019
    Manufacturer
    VALLEY ELECTRONICS AG
    Product Code
    LHD
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE NO SUCH CASES REPORTED OR KNOWN TO THE MANUFACTURER IN THE PAST. PER THE PATIENT, SHE WAS USING THE DAYS DEVICE DAILY SINCE SHE PURCHASED DAYS IN (B)(6) 2019. MOST LIKELY, THERE WAS NO CONTAMINATION FROM PRODUCTION OR TRANSPORTATION, SINCE CANDIDA IS PRESENT IN THE MOUTH OF HUMANS. THE PATIENT STATED THAT SHE WAS NOT CLEANING THE DEVICE BETWEEN USE (THE IFU STATES THAT IT SHOULD BE CLEANED). THE USER PROVIDED PHOTOS SHOWING THERE WAS NO PHYSICAL DAMAGE TO THE DEVICE SPECIFICALLY THE TIP OF THE SENSOR BEING IN CONTACT WITH THE MUCUS. HENCE, THE DEVICE MOST LIKELY DID NOT CAUSE MICRO LESIONS DUE TO SHARP EDGES. ALSO, THERE WERE NO DIRT PARTICLES VISIBLE IN THE PICTURES. FURTHERMORE, THE PATIENT STATED TO HAVE DISCOMFORT WHILE USING THE DEVICE BEFORE THE ADVERSE EVENT. AFTER REQUEST SHE CONFIRMED TO HAVE OVERINSERTED THE DEVICE (IFU WARNS NOT TO OVERINSERT THE DEVICE) AND SUSPECTS THIS TO BE THE ROOT CAUSE FOR THE ORAL THRUSH. TO THIS POINT IT IS UNCLEAR WHETHER OR NOT UNTREATED CANDIDIASIS MAY LEAD TO SYSTEMIC CANDIDIASIS POTENTIALLY PUTTING THE PATIENT INTO A SITUATION OF SERIOUS INJURY MEANING PERMANENT DAMAGE TO A BODY FUNCTION OR PART. OUR REPORT IS PAST THE 30 DAY REPORTING MARK DUE DELAYS IN GETTING A FUNCTIONING PRODUCTION ACCOUNT FOR THE ESUBMITTER/WEB TRADER.

    Description of Event or Problem · 1

    PATIENT EXPERIENCED DISCOMFORT AT SPOT IN MOUTH WHERE DAILY TEMPERATURE MEASURING OCCURRED AND DEVELOPED THRUSH. MEDICINE WAS PRESCRIBED BY PATIENTS DOCTOR. PATIENT WENT TO HER DOCTOR FOR THE THRUSH AND WAS PRESCRIBED NYSTATIN ORAL SUSPENSION AND DIFLUCAN 2 PILLS TO CURE THE FUNGAL INFECTION (CANDIDIASIS) IN HER MOUTH. PATIENT IS CURRENTLY IN GOOD AND HEALTHY CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    999855 DAYSY DAYSY FERTILITY TRACKER LHD VALLEY ELECTRONICS AG 12-2018

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention