Hygenic H02146Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI D661H021461), received between Sep 13, 2018 and Aug 27, 2021 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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.

• InjuryAug 27, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  THE CUSTOMER INITALLY REPORTED THAT THE DENTAL DAM TEARS VERY QUICKLY. IT WAS CONFIRMED ON (B)(6) 2021 THAT THE DENTAL DAM TORE DURING TREATMENT AND THAT THE ROOT CANAL TREATMENT HAD TO BE RESTARTED. THE CUSTOMER WAS CONTACTED ON (B)(6) 2021 TO OBTAIN ADDITIONAL INFORMATION REGARDING ANY OTHER MEDICAL DEVICES THAT WERE BEING USED AT THE TIME OF THE INCIDENT AND TO DETERMINE THE NUMBER OF PATIENTS THAT WERE AFFECTED. DURING THIS FOLLOW UP, IT WAS DETERMINED THAT AN ADVERSE EVENT DID NOT ACTUALLY OCCUR. THE DENTIST INDICATED THAT THE DENTAL DAM TORE PRIOR TO PROCEDURE AND WAS JUST PROVIDING AN EXAMPLE OF WHAT COULD HAVE HAPPENED IF THE DENTAL DAM WOULD HAVE TORN DURING PROCEDURE (RESTART THE ROOT CANAL TREATMENT).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12377989 ↗
• InjuryAug 27, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  THE CUSTOMER INITIALLY REPORTED THAT THE DENTAL DAM TEARS VERY QUICKLY. IT WAS CONFIRMED ON (B)(6) 2021 THAT THE DENTAL DAM TORE DURING TREATMENT AND THAT THE ROOT CANAL TREATMENT HAD TO BE RESTARTED. THE CUSTOMER WAS CONTACTED ON (B)(6) 2021 TO OBTAIN ADDITIONAL INFORMATION REGARDING ANY OTHER MEDICAL DEVICES THAT WERE BEING USED AT THE TIME OF THE INCIDENT AND TO DETERMINE THE NUMBER OF PATIENTS THAT WERE AFFECTED. DURING THIS FOLLOW UP, IT WAS DETERMINED THAT AN ADVERSE EVENT DID NOT ACTUALLY OCCUR. THE DENTIST INDICATED THAT THE DENTAL DAM TORE PRIOR TO PROCEDURE AND WAS JUST PROVIDING AN EXAMPLE OF WHAT COULD HAVE HAPPENED IF THE DENTAL DAM WOULD HAVE TORN DURING PROCEDURE (RESTART THE ROOT CANAL TREATMENT).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12377770 ↗
• MalfunctionSep 13, 2018Break; Product Quality Problem; Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE DENTIST, THE PRODUCT BREAKS VERY EASILY AND CAN NOT BE USED. DAM BROKE DURING PROCEDURE.

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

  MAUDE report 7873960 ↗