Skip to content

Mizzy Millennium 6010049Recalls & reported problems

Keystone Industries · Denture Acrylic QC Liquid · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI H66860100491), received between Oct 22, 2021 and Oct 22, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Device Appears to Trigger Rejection1

Patient problems

  • Hypersensitivity/Allergic reaction1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryOct 22, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

    DOCTOR REPORTED HER PATIENT COMPLAINED OF A ALLERGIC REACTION TO WHAT HE THINKS WAS THE MONOMER. PATIENT WENT TO ER BECAUSE OF PAIN AND WAS PRESCRIBED ANTIBIOTICS, CHLOROHEXIDINE AND BENADRYL.

    Patient problems: Hypersensitivity/Allergic reaction

    MAUDE report 12684062 ↗

Other RESIN, DENTURE, RELINING, REPAIRING, REBASING devices

All RESIN, DENTURE, RELINING, REPAIRING, REBASING devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.