hydrogum C302025Recalls & reported problems
Zhermack SPA · Alginate impression material · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI EZHIC3020250), received between Sep 18, 2024 and Sep 18, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Patient-Device Incompatibility1
Patient problems
- Hypersensitivity/Allergic reaction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 18, 2024Patient-Device Incompatibility; Patient-Device Incompatibility
IN THIS EVENT IT IS REPORTED THAT A PATIENT HAD A REACTION TO HYDROGUM LL BUSTA 500 G. THAT CAUSED BLISTERS.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 20246571 ↗
Other MATERIAL, IMPRESSION devices
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- Jeltrate® Dustless Alginate Impression Material 605224Dentsply International Inc. · MATERIAL, IMPRESSION19 reports
- Jeltrate® Chroma Dustless Color-Changing Alginate Impression Material 605700Dentsply International Inc. · MATERIAL, IMPRESSION7 reports
- Impression Kit StandardStraight Smile LLC · Material, Impression4 reports
- neocolloid C302205Zhermack SPA · MATERIAL, IMPRESSION2 reports
- tropicalgin C302240Zhermack SPA · MATERIAL, IMPRESSION1 report
- Aquasil® Ultra+ Smart Wetting® Impression Material 678684Dentsply International Inc. · MATERIAL, IMPRESSION1 report
- Express™ 73123m Company · MATERIAL, IMPRESSION1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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