HurriSeal Dentin Desensitizer 12mL 12mL bottleRecalls & reported problems
Beutlich Pharmaceuticals, LLC · Dentin desensitizing liquid formula. 1 x 12mL bottle in a box. · Class 2
Data updated Oct 18, 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 10723797697822), received between Aug 22, 2024 and Aug 22, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Patient Device Interaction Problem1
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.
InjuryAug 22, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
ON THURSDAY JULY 25, 2024 BEUTLICH REGULATORY AFFAIRS RECEIVED INFORMATION FROM A DENTAL OFFICE REQUESTING INGREDIENT INFORMATION FOR THE MEDICAL DEVICE, HURRISEAL. IN SPEAKING WITH THE CALLER, REGULATORY PERSONNEL WAS TOLD THAT THE HURRISEAL DEVICE PRODUCT WAS USED ON A PATIENT (FEMALE, 33 YEARS OLD) WHO WAS HAVING VENEERS APPLIED TO SEVERAL (12) TOP AND FRONT TEETH. IT WAS REPORTED TO BEUTLICH THAT THE PATIENT RECEIVED INITIAL SERVICES ON (B)(6) 2024 AND THE NEXT DAY COMPLAINED TO THE DENTAL OFFICE THAT HER LIP WAS RED AND SWOLLEN AND FELT "WEIRD". THIS MESSAGE WAS RELAYED TO THE DENTIST WHO THOUGHT IT MAY HAVE BEEN SOME KIND OF AN ALLERGIC REACTION AND CALLED IN A MEDROL STEROID PACK FOR THE PATIENT. THE PATIENT CALLED THE DENTAL OFFICE AGAIN LATER ON (B)(6) 2024 STATING HER GUMS WERE NOW "FIRE ENGINE RED" AND SWOLLEN. THE DENTIST REQUESTED THE PATIENT COME IN TO THE OFFICE FOR EXAMINATION AND FOUND THAT THE STEROID PACK HAD RELIEVED THE ISSUE WITH THE PATIENT'S LIP, BUT HER GUMS WERE STILL AFFECTED; RED AND INFLAMED. THE FOLLOWING DAY, (B)(6) 2024 THE PATIENT STATED THAT HER GUMS HAD TURNED A WHITE GRAY COLOR AND WAS SLOUGHING SKIN. ON (B)(6) 2024 THE PATIENT REPORTED THAT HER
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 20035946 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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