Description of Event or Problem · 0
MULTIPLE CONSUMERS REPORTED THIS DENTAL CEMENT FAILING TO HOLD CROWNS OR FILLINGS, CAUSING BROKEN CROWNS, TOOTH PAIN, SUSPECTED ENAMEL DAMAGE. THE CEMENT OFTEN CRUMBLES OR DISSOLVES, AND SOME KITS ARRIVED OPENED OR TAMPERED. PRODUCT LACKS WARNINGS FOR VENEERS OR DENTURES. THIS PRODUCT IS AVAILABLE FOR CONSUMER PURCHASE WITHOUT 510(K) CLEARANCE. CONSUMERS IMPACTED ARE VARIOUS AGES, SEXES, AND RACE. BETWEEN APRIL 2024 AND JULY 2025, OVER 600 NEGATIVE CONSUMER REVIEWS WERE POSTED ON AMAZON FOR THE MASTERMEDI ZINC OXIDE EUGENOL CEMENT DENTAL CARE KIT. THIS PRODUCT IS A CLASS II MEDICAL DEVICE (21 CFR 872.3275) INTENDED FOR USE BY DENTAL PROFESSIONALS ONLY YET IS WIDELY SOLD DIRECTLY TO CONSUMERS. A REVIEW OF PUBLIC COMPLAINTS REVEALS THE FOLLOWING MAJOR PATTERNS: -DEVICE MALFUNCTION (502+ REPORTS): CONSUMERS REPORT THAT THE CEMENT CONSISTENTLY FAILS TO ADHERE CROWNS OR FILLINGS, OFTEN FALLING OUT WITHIN HOURS OR DAYS, CRUMBLING, OR DISSOLVING WHEN EXPOSED TO SALIVA OR WATER. MANY NOTE THE PRODUCT IS DIFFICULT OR IMPOSSIBLE TO USE AS INTENDED, EVEN WHEN FOLLOWING INSTRUCTIONS EXACTLY. -INJURY OR PAIN (20+ REPORTS): MULTIPLE USERS EXPERIENCED DENTAL INJURY OR INCREASED PAIN, INCLUDING CRACKED OR BROKEN CROWNS AFTER ATTEMPTED REMOVAL, PAIN FROM POORLY FITTING CROWNS, AND SUSPECTED ENAMEL DAMAGE. AT LEAST ONE USER REPORTED A CROWN BREAKING IN HALF DUE TO CEMENT. -QUALITY AND SAFETY CONCERNS (10+ REPORTS): USERS DESCRIBE RECEIVING KITS THAT WERE ALREADY OPENED, UNSEALED, OR APPEARED PREVIOUSLY USED, RAISING RISK FOR CONTAMINATION OR EXPOSURE TO UNKNOWN SUBSTANCES. -LABELING/USE ERROR (10+ REPORTS): MANY CONSUMERS ATTEMPTED TO USE THE CEMENT FOR VENEERS, PARTIALS, OR DENTURES, DUE TO LACK OF ADEQUATE WARNINGS OR INSTRUCTIONS. THIS RESULTED IN FURTHER DENTAL DAMAGE OR REQUIRED ADDITIONAL DENTAL PROCEDURES. -SETTING TIME ISSUES (15+ REPORTS): CONSUMERS FREQUENTLY REPORT THAT THE CEMENT SETS EITHER TOO FAST TO ALLOW APPLICATION OR DOES NOT HARDEN IN A REASONABLE TIME, CONTRIBUTING TO DEVICE FAILURE. THESE RECURRING PROBLEMS HIGHLIGHT THE DANGERS OF MAKING THIS DEVICE AVAILABLE FOR UNSUPERVISED USE BY THE PUBLIC. THE LACK OF PROFESSIONAL OVERSIGHT LEADS TO IMPROPER APPLICATION, MISSED DIAGNOSES OF UNDERLYING DENTAL CONDITIONS, AND INCREASED RISK FOR PATIENT INJURY AND DEVICE MALFUNCTION. THERE IS CLEAR EVIDENCE OF HARM TO CONSUMERS, AS WELL AS WIDESPREAD PRODUCT QUALITY AND LABELING ISSUES. PRODUCT LISTING: BRAND: MASTERMEDI, LISTING LINK: HTTPS://A.CO/D/EPBMDXI MAJOR COMPLAINT CATEGORIES: COMPLAINT TYPE NUMBER OF REPORTS DESCRIPTION/NOTES DEVICE MALFUNCTION 502+ FAILS TO ADHERE, CRUMBLES, OR FALLS OUT SOON AFTER USE INJURY OR PAIN 20+ CRACKED/BROKEN CROWNS, TOOTH PAIN, ENAMEL DAMAGE QUALITY/SAFETY CONCERNS 10+ OPENED/UNSEALED KITS, POSSIBLE CONTAMINATION LABELING/OFF-LABEL USE 10+ NO WARNINGS FOR VENEERS/PARTIALS, LEADING TO DENTAL INJURY SETTING TIME ISSUES 15+ SETS TOO FAST/SLOW, UNPREDICTABLE PERFORMANCE.