MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-12 for HURRISEAL DENTIN DESENSITIZER 12ML manufactured by Beutlich Pharmaceuticals, Llc.
[105371328]
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.
Patient Sequence No: 1, Text Type: N, H10
[105371329]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001413399-2018-00001 |
| MDR Report Key | 7426942 |
| Date Received | 2018-04-12 |
| Date of Report | 2018-02-16 |
| Date of Event | 2018-01-16 |
| Date Mfgr Received | 2018-01-19 |
| Device Manufacturer Date | 2016-02-01 |
| Date Added to Maude | 2018-04-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. BRENT JACQUART |
| Manufacturer Street | 7775 S. US HWY 1 UNIT H |
| Manufacturer City | BUNNELL FL 321103827 |
| Manufacturer Country | US |
| Manufacturer Postal | 321103827 |
| Manufacturer Phone | 3862638860 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HURRISEAL DENTIN DESENSITIZER |
| Generic Name | AGENT, TOOTH BONDING, RESIN - DESENSITIZER |
| Product Code | KLE |
| Date Received | 2018-04-12 |
| Returned To Mfg | 2018-02-12 |
| Model Number | 12ML |
| Lot Number | Y048EP |
| Device Expiration Date | 2019-02-28 |
| Operator | DENTIST |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BEUTLICH PHARMACEUTICALS, LLC |
| Manufacturer Address | 7775 S. US HWY 1 UNIT H BUNNELL FL 321103827 US 321103827 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2018-04-12 |