neocolloid C302205Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI EZHIC3022050), received between Jun 9, 2023 and Apr 5, 2024 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• InjuryApr 5, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  IN THIS EVENT IT IS REPORTED THAT NEOCOLLOID LL BUSTA 500 G. WAS USED IN A FULL MOUTH IMPRESSION THAT WAS TAKEN USING THE PRODUCT IN THE ORAL CAVITY. THE NEXT DAY, THE PATIENT REPORTED THAT THEIR GUMS WERE SWOLLEN AND UNCOMFORTABLE. AFTER ORAL EXAMINATION, IT WAS FOUND THAT REDNESS, SWELLING, AND WHITE PUNCTATE PLAQUES WERE PRESENT IN THE MUCOSAL FOLDS OF BILATERAL MAXILLARY NODULES. LOCAL IODINE GLYCERIN WAS APPLIED AND MOUTHWASH WAS USED TO RINSE THE MOUTH. THE PATIENT WAS ADVISED TO OBSERVE. EVENT CAUSE ANALYSIS DESCRIPTION MENTIONED BY DOCTOR: ALGINATE IMPRESSION MATERIAL HAS A STIMULATING EFFECT ON MUCOUS MEMBRANES.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 19048993 ↗
• InjuryJun 9, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  IN THIS EVENT IT IS REPORTED THAT NEOCOLLOID LL BUSTA 500 G. DURING USE PATIENT DEVELOPED MUCOSAL SWELLING AFTER USING THE PRODUCT TO TAKE IMPRESSION. A SALINE GARGLE WAS GIVEN AND SYMPTOMS IMPROVED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 17098119 ↗