MAUDE Adverse Event Report: BEUTLICH PHARMACEUTICALS, LLC HURRISEAL DENTIN DESENSITIZER

Model Number	12ML
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	07/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
With administration of steroid and discontinue use of the device, the patient's symptoms abated and tissues returned to normal within days.
Event or Problem Description
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 gums were returning to normal and on (b)(6) 2024 was seen by the dentist who recorded that her gums had appeared to be back to normal.Several requests have been made for the return of the remaining device for additional analysis, but it is not available at the time of this initial report.

• Brand Name: HURRISEAL DENTIN DESENSITIZER
• Common Device Name: DENTIN DESENSITIZER
• Manufacturer (Section D): BEUTLICH PHARMACEUTICALS, LLC; 7775 s. us highway 1; unit h; bunnell FL 32110 3827
• Manufacturer (Section G): DENTAL TECHNOLOGIES, INC.; 6901 n. hamlin avenue; lincolnwood IL 60712
• Manufacturer Contact: brent jacquart ; 7775 south us highway 1; unit h; bunnell, FL 32110-3827 ; 8002388542
• MDR Report Key: 20035946
• Report Number: 0001413399-2024-00001
• Device Sequence Number: 3035129
• Product Code: KLE
• UDI-Device Identifier: 10723797697822
• UDI-Public: (01)10723797697822(17)260630(10)F156KP
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K973002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 08/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 06/30/2026
• Device Model Number: 12ML
• Device Catalogue Number: 0283-0697-82
• Device Lot Number: F156KP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2024
• Initial Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/09/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HURRISEAL DENTIN DESENSITIZER
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 33 YR
• Patient Sex: Female