NA 00712804Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00724995184162), received between Mar 25, 2022 and Apr 3, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2025Material Discolored; Insufficient Device Problem Information; Material Discolored; Insufficient Device Problem Information

  THE USER FACILITY REPORTED VIA MEDWATCH (B)(4) THAT THERE WERE BROWN DOTS OBSERVED ON THE PLASTIC PACKAGE OF THEIR BITE BLOCK. THE BITE BLOCK WAS NOT UTILIZED IN A PATIENT PROCEDURE. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21767011 ↗
• MalfunctionOct 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE A PIECE OF THEIR BITE BLOCK MAXI, LATEX FREE STRAP DETACHED AND HAD TO BE REMOVED FROM THE PATIENT USING A SCOPE. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20476630 ↗
• MalfunctionMar 25, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  THE USER FACILITY REPORTED THAT DURING USE OF BITE BLOCKS, PATIENTS WERE OBTAINING CUTS IN THEIR MOUTH. NO MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.

  Patient problems: Laceration(s)

  MAUDE report 13902571 ↗