BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRIDA FERTILITY AT-HOME INSEMINATION SET - 3CT

    MDR report key: 16963284 · Received May 18, 2023

    Report

    Report Number
    MW5117725
    Event Type
    Injury
    Date Received
    May 18, 2023
    Report Date
    May 16, 2023
    Manufacturer
    FRIDA FERTILITY / FRIDABABY LLC
    Product Code
    HGD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    USING THE FRIDA FERTILITY AT HOME INSEMINATION KIT I GOT A UTI AND NEEDED ANTIBIOTICS. I WENT ON THEIR WEBSITE AND FOUND OUT THEY WEREN'T STERILE OR FDA CLEARED. I MIGHT NOT BE ABLE TO HAVE CHILDREN THEN. AT-HOME INSEMINATION SET $49.99 4.6 OUT OF 5 STARS. READ REVIEWS FOR AVERAGE RATING VALUE IS 4.6 OF 5. READ 32 REVIEWS SAME PAGE LINK. 4.6 (32) WRITE A REVIEW TRYING CAN BE TRYING. THAT'S WHY THIS SIMPLE AT-HOME SYSTEM WAS THOUGHTFULLY DESIGNED WITH FERTILITY SPECIALISTS - WITH BOTH PARTIES IN MIND. INCLUDES 2 ONE-TIME USE APPLICATORS WITH A COMFORT GRIP + EXTENDED BARREL TO COMFORTABLY DELIVER SEMEN. PLUS ONE REUSABLE SPERM CUP WITH A SLANTED SCOOP + ROUNDED BOTTOM TO ENSURE NO SEMEN IS LEFT BEHIND. HOW IT WORKS: TRYING CAN BE TRYING. THAT'S WHY THIS SIMPLE AT-HOME SYSTEM WAS THOUGHTFULLY DESIGNED - WITH BOTH PARTIES IN MIND. APPLICATORS: A COMFORT GRIP FOR ONE-HANDED HOLD, ROUNDED TIP FOR COMFORT RELEASE AND EXTENDED BARREL FOR DEPOSIT EASE. COLLECTION CUP: A SLANTED SCOOP FOR NO WASTED SPILLAGE AND ROUNDED BOTTOM TO ENSURE NO SEMEN IS LEFT BEHIND. DEVELOPED WITH: FERTILITY SPECIALISTS. SIMPLE AS: COLLECT, INSERT, WAIT 5-15M. MADE IN THE USA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666635 FRIDA FERTILITY AT-HOME INSEMINATION SET - 3CT APPLICATOR, VAGINAL HGD FRIDA FERTILITY / FRIDABABY LLC FRIDA FERTILITY

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Unknown Required Intervention| O