IRM® Intermediate Restorative Material 610007Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI D0026100071), received between Mar 19, 2025 and Mar 19, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (2 reports).

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 19, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IN THIS EVENT IT IS REPORTED THAT IRM POWDER 40G THAT WAS USED IN TREATMENT, THE PATIENT DEVELOPED AN ALLERGIC REACTION AND HAD TO BE HOSPITALIZED. NO INFORMATION ABOUT SIGNS AND SYMPTOMS HAS BEEN SHARED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 21641515 ↗
• InjuryMar 19, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IN THIS EVENT IT IS REPORTED THAT IRM LIQUID 15ML THAT WAS USED IN TREATMENT, THE PATIENT DEVELOPED AN ALLERGIC REACTION AND HAD TO BE HOSPITALIZED. NO INFORMATION ABOUT SIGNS AND SYMPTOMS HAS BEEN SHARED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 21641488 ↗