CHATTANOOGA 27812Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888912293853), received between May 10, 2017 and Mar 9, 2020 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Overheating of Device” (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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 9, 2020Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT "THE UNIT WAS GETTING TOO HOT". THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9805356 ↗
• InjuryJul 9, 2019Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT THE PATIENT "GOT A SENSATION OF BEING BURNED, CAUSED BLISTERS AND IRRITATION ON PATIENT". NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 8772707 ↗
• InjuryMay 10, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPLAINT RECEIVED THAT ALLEGES "SHE HAD RECEIVED TREATMENT TO HER FACE FOR TMJ WITHOUT GLASSES. SINCE THE TREATMENT SHE HAS HAD TROUBLES WITH DISTORTED VISION, HER EYES HURT AND ARE HARD TO KEEP OPEN, AND SHE HAS HAD SOME SPELLS OF DIZZINESS. SHE SOUGHT HELP FROM HER OPTOMETRIST BUT THEY WERE UNABLE TO GIVE CLEAR ANSWER". QUESTIONNAIRE NOT RECEIVED FROM CUSTOMER OR CLINICIAN. DEVICE NOT RETURNED TO MANUFACTURER FOR EVALUATION.

  Patient problems: Blurred Vision; Dizziness; Pain

  MAUDE report 6557202 ↗