inforMED
MalfunctionKHE

FIT COLON CANCER SCREENING TEST EVERLYWELL

Received Jan 23, 2023 · Event occurred Jan 16, 2023

Report MW5114471 · MDR key 16235045

Device

Generic name

Reagent, Occult Blood

Manufacturer

Unk

Model number

K-EVW-00841/011

Product problems

  • Device Markings/Labelling Problem

Patient

35 YR · Male

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

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.