MAUDE Adverse Event Report: FIT COLON CANCER SCREENING TEST EVERLYWELL; REAGENT, OCCULT BLOOD

Model Number K-EVW-00841/011

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/16/2023

Event Type  malfunction  

Event Description

Everylwell sells a colon cancer screening kit that does not clearly state the age restriction of 45 on the kit.It says it on the back but the printing is very small and there is no attempt to draw attention to it on the front of the package or elsewhere (such as a question at checkout).On the back in the info section it says one must be 45 but there is no bold print on it, not is it underlined or identified in any other way.I don't know if it is an ama or fda restriction on under 45s not doing a test for colon cancer, but it is a stupid policy.I paid for it myself with cash and i should be able to test myself for something that could potentially kill me.Maybe that's why its a good thing that congress is looking to pass a law to ban regulations by non-senate confirmed federal employees.In any event, the maker does not clearly state on its box in an easy to find place that they cannot let people under 45 use the test.This is clearly a deceptive business practice and must catch hundreds, if not more, consumers.

• Brand Name: FIT COLON CANCER SCREENING TEST EVERLYWELL
• Type of Device: REAGENT, OCCULT BLOOD
• MDR Report Key: 16235045
• MDR Text Key: 308097868
• Report Number: MW5114471
• Device Sequence Number: 1
• Product Code: KHE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/26/2023
• Device Model Number: K-EVW-00841/011
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/23/2023
• Patient Sequence Number: 1
• Treatment: DGL LICORICE SUPPLEMENT; PROBIOTICS; SLIPPERY ELM SUPPLEMENTS
• Patient Age: 35 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White