Hysolate H09946Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630392901208), received between Sep 19, 2024 and Sep 19, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 19, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CUSTOMER STATED THAT THEY HAD A PATIENT EXPERIENCE CONTACT DERMATITIS DUE TO USE OF THE NON-LATEX DAM. THE REACTION WAS NON-SERIOUS AND WAS CONTROLLED WITH TOPICAL MEDICATIONS WITHOUT ANY FURTHER MEDICAL INTERVENTIONS. THE PRODUCT WAS BEING USED WITH SINGLE TOOTH ISOLATION DURING AN ENDODONTIC PROCEDURE AND THE DENTAL DAM DID NOT TEAR. THE INFORMATION PROVIDED REASONABLY SUGGESTS THAT THE MEDICAL DEVICE "CAUSED OR CONTRIBUTED" TO AN INJURY AS THE PATIENT HAD TO SEEK MEDICAL ATTENTION. FOR THIS REASON, OUT OF AN ABUNDANCE OF CAUTION, AND PER 21 CFR 803, THE EVENT IS REPORTABLE.

  Patient problems: Contact Dermatitis

  MAUDE report 20263343 ↗