MAUDE Adverse Event Report: BEUTLICH PHARMACEUTICALS, LLC HURRISEAL DENTIN DESENSITIZER; AGENT, TOOTH BONDING, RESIN - DESENSITIZER

Model Number 12ML

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Unspecified Infection (1930); Rash (2033); Swelling (2091)

Event Date 01/16/2018

Event Type  Injury  

Manufacturer Narrative

Investigation is ongoing pending analytical results of the returned medical device.Beutlich is not aware of any additional treatments/devices/drugs applied concurrently to the patient, nor are we aware of any patient conditions or risk factors which may have contributed to the reported adverse conditions experienced by the patient.As information is gathered at the conclusion of the investigation and analytical testing, beutlich will submit a supplemental report.It is anticipated to have all data acquired on or before march 31, 2018.Complete analysis of the returned device revealed no characteristic out of specification range.No failure of the medical device could be determined.No determination can be made regarding the proper device usage according to the ifu, however the reporter described a history of correct practice with the device.It is the conclusion of this investigation that there may have been some level of sensitivity on the part of the patient to one or more ingredients within the device formula.This is a known and documented risk with this device and has been reduced as far as possible, but not eliminated.

Event Description

On friday (b)(6) 2018 beutlich regulatory affairs was contacted by dr.(b)(6) stating that a patient had reported being treated for pain, blisters, swelling, and thrush in the oral cavity following a procedure involving hurriseal dentin desensitizer.According to the dentist, the patient, (b)(6) year old female, was treated on (b)(6) 2018 with hurriseal lot y048ep according to the enclosed ifu (isolated with cotton, application with micro brush, allowed to dry, repeat.) for relief of the patient hypersensitivity to cold.Following this application, the patient reported back to the dentist office (b)(6) that she required medical treatment at a local hospital for: blisters to the inside of both cheeks, swelling of the tongue, and a rash.The patient reported that the hospital determined she had oral candidiasis "thrush" and she received care from the hospital in the form of an antihistamine, application of an oral paste, and an oral rinse.She was then discharged.Any further attempts from hilltop dentistry to contact the patient for updated information were unsuccessful and, to date, have been unanswered.

• Brand Name: HURRISEAL DENTIN DESENSITIZER
• Type of Device: AGENT, TOOTH BONDING, RESIN - DESENSITIZER
• Manufacturer (Section D): BEUTLICH PHARMACEUTICALS, LLC; 7775 s. us hwy 1; unit h; bunnell FL 32110 3827
• Manufacturer Contact: brent jacquart ; 7775 s. us hwy 1; unit h; bunnell, FL 32110-3827 ; 3862638860
• MDR Report Key: 7426942
• MDR Text Key: 105371328
• Report Number: 0001413399-2018-00001
• Device Sequence Number: 1
• Product Code: KLE
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K973002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 02/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Expiration Date: 02/28/2019
• Device Model Number: 12ML
• Device Lot Number: Y048EP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 58 YR