MAUDE Adverse Event Report: FRIDA FERTILITY / FRIDABABY LLC FRIDA FERTILITY AT-HOME INSEMINATION SET - 3CT; APPLICATOR, VAGINAL

Model Number FRIDA FERTILITY

Device Problem Use of Device Problem (1670)

Patient Problem Urinary Tract Infection (2120)

Event Type  Injury  

Event Description

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.

• Brand Name: FRIDA FERTILITY AT-HOME INSEMINATION SET - 3CT
• Type of Device: APPLICATOR, VAGINAL
• Manufacturer (Section D): FRIDA FERTILITY / FRIDABABY LLC
• MDR Report Key: 16963284
• MDR Text Key: 315735554
• Report Number: MW5117725
• Device Sequence Number: 1
• Product Code: HGD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: FRIDA FERTILITY
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/18/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 18 YR
• Patient Ethnicity: Hispanic
• Patient Race: Native Hawaiian Or Other Pacific Islander