FDA Adverse Event Injury Summary report: N

AMASSE BIO-FLUID COLLECTION DEVICE

MDR report key: 21994688 · Received May 9, 2025

Report

Report Number
MW5170174
Event Type
Injury
Date Received
May 9, 2025
Date of Event
April 21, 2025
Report Date
May 4, 2025
Manufacturer
OPANS LLC
Product Code
OQS
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
WV, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

THE AMASSE BIOFLUID COLLECTION DEVICE IS BEING G USED WITHIN THE JUDICIAL SYSTEM AND COUNTLESS EXPERT TESTIMONY SAY THEY DON¿T ALLOW FOR CHEMICAL IDENTIFICATION. THIS DEVICE IS PUTTING PEOPLE BEHIND BARS AND STEALING CHILDREN FROM LOVING PARENTS. I'VE SEEN YOU ALL HAVE COUNTLESS REPORTS ON THIS DEVICE YET YOU'RE STILL ALLOWING THIS MONSTROSITY TO CORRUPT THE INTEGRITY OF THE UNITED STATES JUDICIAL SYSTEM. I'VE BOUGHT THIS MATTER TO YOUR ATTENTION BEFORE AND AM AGAIN. WHEN AN EXPERT WITH A PHD AND TOXICOLOGY AND PHARMACEUTICALS WHO ALSO HAVE GOVERNORS' RECOGNITION FOR HER WORK IS FIGHTING AGAINST THIS DEVICE IN COURT TO TRY AND STOP THE ILLEGAL DEVICE THAT DOESN¿T EVEN HAVE PRE-MARKET NOTIFICATION WITH THE FDA TO EVEN BE SOLD IN AMERICA. WHAT'S THE HOLD UP. MY FEDERAL CLAIMS LAWSUIT SHOULD ALSO INCLUDE THE FDA FOR ALLOWING THIS TO TRANSPIRE AND CONTINUOUSLY HARM AMERICAN CITIZENS. WRONGFULLY IMPRISON CITIZENS AND VIOLATED THEIR CONSTITUTIONAL RIGHTS TO REAL DUE PROCESS. VIOLATING COUNTLESS AMENDMENT INCLUDING THE 14TH AMENDMENT. YOU ALL SHOULD BE ASHAMED OF YOURSELVES FOR ALLOWING THIS TO HAPPEN INSTEAD OF PUTTING A STOP TO IT. HAIR FOLLICLES AND EVEN UMBILICAL CORDS HAVE PROVEN IT WRONG AND YET YOUR ALL SETTING ON YOUR HANDS. WHAT AMOUNT OF MONEY IS MAKING THIS SITUATION BEING OVERLOOKED. HOW MANY MORE EXPERTS MUST GIVE EXPERT TESTIMONY PROVING THE DEVICE IS A SCAM BEFORE Y¿ALL DO SOMETHING? THE DEVICE HAS NO FDA DATA WITHIN YOUR DATABASE AND EXPERTS HAVE PROVEN IT DOESN'T EVEN ALLOW FOR CHEMICAL IDENTIFICATION. YOU¿VE GOT THE PHOTO OF THE DEVICE. THE OVER EVEN KNOWS FAILURE TO DRY THE BLOOD SPOT BEFORE PACKAGING IS A PROBLEM. I'LL SEND THE PICTURE. PLUS, THE DEVICE IS BEING USED IMPROPERLY WITHIN A JUDICIAL SYSTEM. THAT'S ILLEGAL IN ITSELF.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1182077 AMASSE BIO-FLUID COLLECTION DEVICE LABORATORY DEVELOPED TEST OQS OPANS LLC

Patients

Seq Age Sex Outcome Treatment
1 39 YR Male Required Intervention| L