FDA Adverse Event Injury Summary report: N

PRIME SCREEN 12-PANEL COMPACT CUP URINE TEST

MDR report key: 23567965 · Received November 17, 2025

Report

Report Number
MW5178926
Event Type
Injury
Date Received
November 17, 2025
Date of Event
November 8, 2025
Report Date
November 12, 2025
Manufacturer
UNK
Product Code
DKZ
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
NC, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

AMAZON PRODUCT TAMPERING & COUNTERFEIT MEDICAL DEVICE COMPLAINT COMPLAINANT: (B)(6). SUMMARY OF COMPLAINT THIS COMPLAINT CONCERNS MULTIPLE AMAZON ORDERS THAT APPEAR TO HAVE BEEN TAMPERED WITH AND REROUTED THROUGH AMAZON'S WNC6 FLEX FACILITY IN (B)(6), AND POSSIBLY OTHER REGIONAL HUBS ((B)(6) ¿ ORF3). THE PRODUCTS RECEIVED ARE MEDICAL-TESTING DEVICES THAT SHOWED SIGNS OF PRIOR OPENING, INCONSISTENT LABELING, AND INACCURATE RESULTS SUGGESTING COUNTERFEIT OR COMPROMISED INTEGRITY. KEY FACTS AND EVIDENCE A. SHIPPING LABELS AND TRACKING, TRACKING IDS: (B)(4). PACKAGES LIST WNC6 ¿ AMAZON FLEX (B)(6) AND ORF3 ¿ (B)(6) CODES. TRACKING PAGES INTERMITTENTLY DISPLAY "PACKAGE NOT FOUND." LABELS REFERENCE LITHIUM-ION BATTERY CONTENT UNRELATED TO THE PRODUCT SHIPPED, SUGGESTING RECYCLED OR MISMATCHED PACKAGING. B. PRODUCT DETAILS: SAFE LIFE T-DIP MULTI-DRUG URINE TEST PANEL (10 PANEL), PRIME SCREEN 12-PANEL COMPACT CUP URINE TEST, LOT NUMBERS X004AS40OL AND X0029Y03K9, EXPIRATION DATES 2026-05 AND 2027-01 RESPECTIVELY; BOTH KITS DISPLAYED BROKEN SEALS AND GAVE INVALID RESULTS (NO THC DETECTION DESPITE KNOWN USE). C. ACCOUNT DISCREPANCIES: DUPLICATE PROFILE DETECTED UNDER THE NAME "(B)(6)" ON MY AMAZON ACCOUNT. POSSIBLE CLONED ACCOUNT USED TO REROUTE ORDERS OR MANIPULATE TRACKING DATA. LEGAL AND REGULATORY VIOLATIONS SUSPECTED; PRODUCT TAMPERING AND CONSUMER FRAUD (15 U.S.C. § 45). MAIL AND WIRE FRAUD (18 U.S.C. § 1341 / § 1343), DISTRIBUTION OF COUNTERFEIT MEDICAL DEVICES (FDA 21 U.S.C. § 331 AND § 333), IDENTITY THEFT / ACCOUNT TAKEOVER (18 U.S.C. § 1028). REQUESTED ACTIONS: IMMEDIATE FORENSIC REVIEW OF PACKAGES PROCESSED THROUGH AMAZON WNC6 (B)(6); INVESTIGATION OF REGIONAL ROUTING AND TRACKING DISCREPANCIES; PRODUCT-INTEGRITY AUDIT OF SAFE LIFE AND PRIME SCREEN TEST KITS RECEIVED; ACCOUNT-SECURITY AUDIT FOR DUPLICATE PROFILE "(B)(6)"; WRITTEN CONFIRMATION OF CORRECTIVE ACTIONS AND REFUND / REPLACEMENT FOR ALL AFFECTED ORDER EVIDENCE ATTACHMENTS EXHIBIT DESCRIPTION SOURCE A AMAZON SHIPPING LABEL (WNC6 / ORF3) ¿ (B)(4), PHOTO 1 B SAFE LIFE 10-PANEL KIT (SEAL IRREGULAR, EXP 2026-05) PHOTO 2 C PRIME SCREEN 12-PANEL CUP (X0029Y03K9, LOT DISCREPANCY) PHOTO 3 D INVALID TEST RESULTS (THC LINE MISSING) PHOTOS 4 & 5 E AMAZON PROFILE SCREENSHOT ¿ DUPLICATE "(B)(6)" PRIOR SUBMISSION RESPECTFULLY SUBMITTED, /(B)(6) DATE: (B)(6) 2025 AFFIDAVIT AND FORMAL COMPLAINT COMPLAINANT: (B)(6). DATE: (B)(6) 2025 SUMMARY OF EMERGENCY MEDICAL INCIDENT I. ON (B)(6) 2025, I CALLED FOR EMERGENCY MEDICAL ASSISTANCE AT APPROXIMATELY 6:23 PM. THE AMBULANCE ARRIVED AT 6:53 PM AND REMAINED IDLE UNTIL 6:55 PM BEFORE TRANSPORTING ME TO (B)(6) HOSPITAL, WHERE I ARRIVED AROUND 7:15 PM AND REMAINED UNTIL ROUGHLY 10:10 PM. DURING THIS EMERGENCY-ROOM VISIT I WAS EVALUATED FOR FACIAL SWELLING AND SEVERE ORAL PAIN. I WAS INFORMED THAT I HAD A DENTAL INFECTION AND HYPERTENSION. THE VISIT SUMMARY IDENTIFIED ORAL SWELLING, DENTAL INFECTION, HISTORY OF SCHIZOPHRENIA, MARIJUANA USE, AND PRIMARY HYPERTENSION AS DIAGNOSES. II. FAILURE TO PROVIDE CARE AND FALSIFIED DOCUMENTATION 1. 2. 3. 4. 5. DESPITE MY REPEATED COMPLAINTS OF PAIN, THE ATTENDING PROVIDER, (B)(6), AND NURSING STAFF FAILED TO ADMINISTER OR PRESCRIBE ANY PAIN MEDICATION THROUGHOUT MY ENTIRE VISIT. CONTRARY TO THE MEDICAL RECORD'S NOTATION, I DID NOT REFUSE PAIN MEDICATION. I EXPLICITLY ASKED TO RECEIVE MEDICATION AFTER MY LAB WORK WAS COMPLETED, AND AFTER LABS WERE TAKEN I AGAIN ASKED THE NURSE--WHO STATED SHE WOULD CHECK WITH THE PROVIDER BUT NEVER RETURNED. I WAS DISCHARGED WITHOUT ANY PRESCRIPTION FOR ANTIBIOTICS OR PAIN MEDICATION, LEAVING THE FACILITY IN THE SAME OR WORSE CONDITION THAN ARRIVAL. WHEN I REQUESTED THAT MY DISCHARGE PAPERS BE CORRECTED TO INCLUDE THE TOXICOLOGY RESULTS AND PROPER CLINICAL FINDINGS, THE STAFF SIMPLY RE-PRINTED THE SAME DOCUMENT. WHEN I ASKED AGAIN, I WAS TOLD "THE DOCTOR ALREADY LEFT." THE TOXICOLOGY SCREEN AND METABOLIC PANEL WERE MISREPRESENTED, AND THE OVERALL DISCHARGE SUMMARY WAS INCOMPLETE AND FRAUDULENT. I THEREFORE REFUSED TO SIGN THE DISCHARGE PAPERWORK. NO STAFF MEMBER SIGNED EITHER. THIS REFUSAL STEMMED FROM THE LACK OF PROPER CARE, FALSIFIED RESULTS, AND INTENTIONAL CONCEALMENT. I'VE EXPERIENCED MULTIPLE INSTANCES WHILE VISITING CAPE FEAR VALLEY MEDICAL CENTER. I'VE FILED OVER 20 COMPLAINTS AND NOTHING HAPPENED. THIS IS RETALIATION FROM THE COMPLAINTS I'VE FILED. THEY TRIED TO POISON ME AND COVER IT UP. PT CODE: 4582. DEVICE CODES: 1444, 1535. REF REPORT: MW5178925.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
273430 PRIME SCREEN 12-PANEL COMPACT CUP URINE TEST ENZYME IMMUNOASSAY, AMPHETAMINE DKZ UNK X0029Y03K9

Patients

Seq Age Sex Outcome Treatment
1 44 YR Female Hospitalization| L| S| R| O CYMBALTA 150MG C39.