Flex F3000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00851826007038), received between Jan 24, 2023 and Feb 24, 2023 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MEDICAL DEVICE REPORT BY IMPORTER: (B)(4). THE MANUFACTURER WAS MADE AWARE ON 01 DEC 2022 THAT THE PATIENT EXPERIENCED AN ALLERGIC REACTION TO THE DEVICE. IT WAS REPORTED THAT THE PATIENT FIRST USED THE DEVICE ON THE EVENING OF (B)(6) 2022 AND WOKE UP THE FOLLOWING MORNING WITH ULCERS ON ORAL SURFACES CONTACTING THE DEVICE, INCLUDING BELOW THE TEETH ON THE GUM LINE, THE LIPS, AND THE UPPER PALATE. THE PATIENT EXPERIENCED MINOR SWELLING IN HER FACE, LIPS, AND THROAT, CAUSING DIFFICULTY SPEAKING BUT THE PATIENT DID NOT EXPERIENCE ANY BREATHING DIFFICULTIES. THE PATIENT WENT TO URGENT CARE FOR TREATMENT OF THE ALLERGIC REACTION. THE PATIENT'S DENTAL PHYSICIAN INSTRUCTED THE PATIENT TO DISCONTINUE USE OF THE DEVICE IMMEDIATELY. THE COMPONENT THAT CAUSED THE ALLERGIC REACTION HAS NOT BEEN IDENTIFIED AT THIS TIME. THE PATIENT'S SYMPTOMS HAVE COMPLETELY RESOLVED AS OF (B)(6) 2022. THE PHYSICIAN HAS STATED INTENT TO RETURN THE DEVICE TO THE MANUFACTURER FOR FURTHER INVESTIGATION.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 16433929 ↗
• InjuryJan 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE IMPORT FACILITY WAS MADE AWARE ON 01 DEC 2022 THAT THE PATIENT EXPERIENCED AN ALLERGIC REACTION TO THE DEVICE. IT WAS REPORTED THAT THE PATIENT FIRST USED THE DEVICE ON THE EVENING OF (B)(6) 2022 AND WOKE UP THE FOLLOWING MORNING WITH ULCERS ON ORAL SURFACES CONTACTING THE DEVICE, INCLUDING BELOW THE TEETH ON THE GUM LINE, THE LIPS, AND THE UPPER PALATE. THE PATIENT EXPERIENCED MINOR SWELLING IN HER FACE, LIPS, AND THROAT, CAUSING DIFFICULTY SPEAKING BUT THE PATIENT DID NOT EXPERIENCE ANY BREATHING DIFFICULTIES. THE PATIENT WENT TO URGENT CARE FOR TREATMENT OF THE ALLERGIC REACTION. THE PATIENT'S DENTAL PHYSICIAN INSTRUCTED THE PATIENT TO DISCONTINUE USE OF THE DEVICE IMMEDIATELY. THE COMPONENT THAT CAUSED THE ALLERGIC REACTION HAS NOT BEEN IDENTIFIED AT THIS TIME. THE PATIENT'S SYMPTOMS HAVE COMPLETELY RESOLVED AS OF (B)(6) 2022. THE PHYSICIAN HAS STATED INTENT TO RETURN THE DEVICE TO THE MANUFACTURER FOR FURTHER INVESTIGATION.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 16236688 ↗