Hygenic H05032Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI D661H050320), received between Jul 8, 2021 and Jul 8, 2021 — classified as 1 injury.

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.

• InjuryJul 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION: THE DENTIST'S OFFICE WAS CONTACTED ON (B)(6) 2021 REGARDING THE COMPLAINT. THE DENTIST OFFICE CONFIRMED THAT ENDO-ICE WAS USED AND THAT IT WAS SPRAYED ON A PELLET IN THE BACK OF THE ROOM AWAY FROM THE PATIENT. ACCORDING TO THE DENTIST NOTES, THE PATIENT CAME IN FOR EVALUATION OF HER LOWER RIGHT AREA. ENDO-ICE WAS SPRAYED ON A COTTON PELLET AT THE BACK OF THE ROOM AND THEN PLACED ON THE TOOTH. THE PATIENT SEEMED TO HAVE A REACTION TO THE ENDO-ICE AND STATED THAT THE FUMES/TASTE BURNED HER THROAT. NO FURTHER COLD TREATMENT WAS PERFORMED BY THE DENTIST. THE DENTIST DID PROVIDE WATER AND MOUTHWASH TO THE PATIENT. THE DENTAL OFFICE INDICATED THAT THE PATIENT DID NOT MENTION ANYTHING ABOUT DRIPS OF ENDO-ICE IN HER THROAT AND THAT ONLY FUMES/TASTES WERE MENTIONED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Chest Pain; Cough; Dyspnea; Fatigue; Sore Throat

  MAUDE report 12134552 ↗