CONMED 00137501100Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10845854018996), received between Feb 16, 2022 and Feb 16, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Excessive Heating” (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 16, 2022Excessive Heating; Excessive Heating

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, 00137501100, BUR GUARD, LONG WAS BEING USED ON (B)(6) 2022 DURING AN ORAL SURGERY BURRING AND THE DEVICE ¿HEATED UP AND BURNT PATIENTS CHEEK¿. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT HAND PIECE AND BUR GUARD AND THERE WAS A 30 MINUTE DELAY TO THE PROCEDURE. THE PATIENT STATUS WAS REPORTED AS ¿GOOD¿. FURTHER ASSESSMENT FOUND, IT IS NOT KNOWN IF TREATMENT WAS GIVEN OR WHAT DEGREE OF BURN WAS RECEIVED. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO UNKNOWN DEGREE OF BURN.

  Patient problems: Burn(s)

  MAUDE report 13542146 ↗