EXAlence™ 137004Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI D6581370041), received between Feb 27, 2018 and Feb 27, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Material Integrity Problem” (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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 27, 2018Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT DID HAVE A KNOWN ALLERGY TO MINT. THE DENTIST HAD AN IMPRESSION MATERIAL THAT THEY KNEW HAD A MINT IN IT AND COULDN'T USE AND DECIDED TO USE EXA'LENCE INSTEAD. THE DENTIST WAS UNAWARE THAT EXA'LENCE HAD ANY MINT FLAVOR IN IT BECAUSE THEY COULD NOT FIND ANY INFORMATION ON THE BOX. AFTER THE PATIENT LEFT THE OFFICE, SHE CONTACTED THE DENTIST OFFICE VIA EMAIL INFORMED THAT SHE WAS EXPERIENCING RESPIRATORY LIKE SYMPTOMS AND CONTACTED HER PHYSICIAN. THE DENTIST OFIICE STATED THAT THE PATIENT TOOK BENADRYL AND IT ALLEVIATED THE PROBLEM AND SHE IS FINE AT THIS TIME.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 7301236 ↗