BEUDAMED
    FDA Adverse Event Injury Summary report: N

    YONIFIT BLADDER SUPPORT

    MDR report key: 25209394 · Received May 18, 2026

    Report

    Report Number
    3031788248-2026-00001
    Event Type
    Injury
    Date Received
    May 18, 2026
    Date of Event
    April 10, 2026
    Report Date
    May 18, 2026
    Manufacturer
    WATKINS-CONTI PRODUCTS, INC.
    Product Code
    HHW
    UDI-DI
    00850019563269
    PMA / PMN Number
    K232525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRESCRIBING OBGYN RAN CULTURES TO TEST FOR YEAST AND BACTERIA AND THE TEST RESULTS WERE ALL NEGATIVE. THE PATIENT REPORTED THAT SHE WAS STILL VOMITING AT THIS APPOINTMENT. DURING THE INVESTIGATION WHEN SPEAKING WITH THE PATIENT'S OBGYN AND A PHYSICIAN ADVISOR TO THE MANUFACTURER, EACH OF THE MEDICAL PROFESSIONALS COULD NOT CONFIRM THAT THE EVENT WAS CAUSED BY YONIFIT; HOWEVER, THE DEVICE WAS BEING USED PRIOR TO THE EVENT OCCURRENCE. THEREFORE, WE ARE REPORTING IN COMPLIANCE WITH THE MDR REQUIREMENTS. THIS IS THE FIRST AND ONLY REPORT TO DATE RECEIVED WHEREIN THE PATIENT EXPERIENCED A UTI AND/OR KIDNEY INFECTION.

    Description of Event or Problem · 0

    AFTER FLYING ON FRIDAY, (B)(6), THE PATIENT STATED THAT SHE EXPERIENCED FLU-LIKE SYMPTOMS. PATIENT STATED SHE REMOVED THE DEVICE AND DID NOT REINSERT. THE PATIENT REPORTED EXPERIENCING LOW-GRADE FEVER AND VOMITING AND ON MONDAY ON (B)(6), THE PATIENT REPORTED THAT SHE SAW HER PRIMARY CARE PHYSICIAN. PATIENT REPORTS THE PHYSICIAN DIAGNOSED HER WITH UTI AND KIDNEY INFECTION. PATIENT REPORTED SHE WAS TREATED WITH ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179818 YONIFIT BLADDER SUPPORT PESSARY, VAGINAL HHW WATKINS-CONTI PRODUCTS, INC. PT-A-0015 26-241212-001 00850019563269

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Other