BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FRIDA FERTILITY AT-HOME INSEMINATION SET - 3CT

    MDR report key: 16887748 · Received May 5, 2023

    Report

    Report Number
    MW5117341
    Event Type
    Malfunction
    Date Received
    May 5, 2023
    Date of Event
    April 28, 2023
    Report Date
    May 2, 2023
    Manufacturer
    FRIDABABY, LLC
    Product Code
    OBB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    UTI (URINARY TRACT INFECTION) AFTER USE OF THE FRIDA INSEMINATION KIT BOUGHT FROM TARGET RETAIL STORE. SPECIFICATIONS: NUMBER OF PIECES: 3. HEALTH FACTS: NON-TOXIC INCLUDES: SYRINGES, COLLECTION CUP MATERIAL: PLASTIC. TCIN: (B)(4). UPC: (B)(4). ITEM NUMBER (DPCI): (B)(4). ORIGIN: MADE IN THE USA AND IMPORTED. 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. MADE IN THE USA. SIMPLE AS: COLLECT, INSERT, WAIT 5-15M. EXTREME PAIN WHEN PEEING AFTER USING THE FRIDA INSEMINATION KIT. FREQUENCY: AT BEDTIME. HOW WAS IT TAKEN OR USED? VAGINAL. DATE THE PERSON FIRST STARTED TAKING OR USING THE PRODUCT: 28-APR-2023. DATE THE PERSON STOPPED TAKING OR USING THE PRODUCT: 28-APR-2023. WHY WAS THE PERSON USING THE PRODUCT? INFERTILITY. THIS IS SUPPOSED TO BE USED TO GET ME PREGNANT. DID THE PROBLEM STOP AFTER THE PERSON REDUCED THE DOSE OR STOPPED TAKING OR USING THE PRODUCT? NO. DID THE PROBLEM RETURN IF THE PERSON STARTED TAKING OR USING THE PRODUCT AGAIN? DIDN'T RESTART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687304 FRIDA FERTILITY AT-HOME INSEMINATION SET - 3CT KIT, CONCEPTION-ASSIST, HOME USE OBB FRIDABABY, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Female Other FRIDA FERTILITY AT-HOME INSEMINATION SET - 3CT FRIDA FERTILITY PRE-CONCEPTION SUPPLEMENTS - 60CT FEMALE BLEND: MADE WITH KEY INGREDIENTS TO MAINTAIN AND SUPPORT EGG FUNCTION [ZINC, SELENIUM], OVARIAN RESERVE [COQ10], REGULAR MENSTRUAL CYCLE [CHASTE TREE BERRY], EARLY FETAL DEVELOPMENT [FOLATE]. MALE BLEND: MADE WITH KEY INGREDIENTS TO MAINTAIN AND SUPPORT SPERM HEALTH [FOLATE, B12], SPERM FUNCTION [COQ10], SPERM STRUCTURE [ZINC, VITAMIN C], TESTOSTERONE LEVELS [ASHWAGANDHA, FENUGREEK].