ENDOBON® ROXLG80Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03599870097588), received between Feb 1, 2019 and Feb 1, 2019 — classified as 1 injury.

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

• InjuryFeb 1, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  THE DOCTOR REPORTED AN ALLERGIC REACTION TO ENDOBON PRODUCT. THE DOCTOR REPORTED THAT SINUS LIFT IN TOOTH POSITION 16 WAS PERFORMED ON (B)(6) 2018. 7 DAYS LATER, AFTER MEDICATION TREATMENT HAD ALREADY BEEN FINISHED, THE PATIENT DEVELOPED AN ALLERGIC REACTION WITH EXANTHEM AND ITCH. THE SYMPTOMS APPEARED IN PARTICULAR IN THE FACE, ON THE NECK AND CLEAVAGE, NOT IN THE PATIENT MOUTH. CORTISONE TREATMENT WAS PERFORMED. AS PATIENT'S CONDITION DID NOT IMPROVE, DOCTOR REMOVED COMPLETELY THE ENDOBON PRODUCT ON (B)(6) 2018. INFORMATION ON PATIENT HEALTH STATUS RECEIVED THE (B)(6) 2018 CONFIRMED THAT THE PATIENT IS WELL AND THE ALLERGY HAS GONE. 2 ENDOBON PRODUCTS WERE INVOLVED IN THIS EVENT. THE INVESTIGATION FOR THE SECOND ENDOBON PRODUCT IS PERFORMED IN THE REPORT FOR (B)(4).

  Patient problems: Reaction

  MAUDE report 8297519 ↗