Hygenic H09105Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI D661H091051), received between Oct 23, 2018 and Jun 25, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 25, 2019Adverse Event Without Identified Device or Use Problem

  AN ALLERGIC REACTION OCCURED AFTER AN OFFICE VISIT FOLLOWING THE USE OF A NON-LATEX DENTAL DAM.

  Patient problems: Reaction

  MAUDE report 8731711 ↗
• MalfunctionOct 23, 2018Material Integrity Problem; Detachment of Device or Device Component; Material Integrity Problem; Material Split, Cut or Torn

  DURING A ROOT CANAL, THE NON-LATEX DENTAL DAM SPLIT AND CAME OFF OVER CLAMP PATIENT WAS UNAWARE OF WHAT HAPPENED. THIS PRODUCT HAS BEEN USED MANY TIMES BEFORE WITHOUT AN ISSUE. ALL PARTS WERE RETRIEVED AND THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7996461 ↗