Hygenic H02706Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI D661H027060), received between Aug 23, 2018 and Jan 29, 2021 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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.

• InjuryJan 29, 2021Fracture; Fracture

  THE CLAMPS BROKE DURING TREATMENT. THE CLAMP WAS FIRST TRIED ON BY CLAMPING IT ONTO THE TOOTH WITH THE FORCEPS. THEN THE RUBBER DAM CLAMP WAS ATTACHED TO THE PATIENT'S TOOTH WITH THE DENTAL DAM AND THE DENTAL DAM FRAME WAS USED. DURING THE TREATMENT THE CLAMP SUDDENLY BROKE AND JUMPED OUT OF THE MOUTH OF THE PATIENT, THE DENTAL DAM CAME OFF THE TOOTH AND SALIVA ENTERED THE TOOTH. THERE WAS NO INJURY TO THE USER; HOWEVER, SALIVA GOT INTO THE TREPANNED TOOTH. DUE TO THE SALIVA INTRUSION, THE TREATMENT HAD TO BE STARTED ALL OVER AGAIN, INCLUDING RE-DRAINING AND THE ADDITIONAL WORKING TIME. OTHERWISE, NO FURTHER MEASURES HAD TO BE TAKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11254458 ↗
• MalfunctionAug 23, 2018Break; Material Integrity Problem; Material Integrity Problem

  DENTAL CLAMP BROKE WHEN PLACING IN MOUTH.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7808723 ↗
• MalfunctionAug 23, 2018Break; Material Integrity Problem; Material Integrity Problem

  DENTAL CLAMP BROKE DURING SET UP.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7808439 ↗