MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-04-25 for EMA NI manufactured by Prismatik Dentalcraft, Inc..
[143224466]
The office advised the reported nightguard was already sent out; however, the nightguard has not been received at the time of this report. Once the nightguard is received and evaluation is completed, a supplemental report will be submitted. This report is for the lower tray of the nightguard. Please reference 3011649314-2019-00131 ((b)(6)) for the upper tray.
Patient Sequence No: 1, Text Type: N, H10
[143224467]
This report is for the lower tray of the nightguard: it was reported that a patient experienced an allergic reaction after using the ema nightguard. After using the nightguard for about 3 months, the patient developed sores on the tip/edge of the tongue and the corners of the lips where they made contact with the nightguard. Upon experiencing the reaction, the patient stopped using the nightguard and the patient started to heal right away. The patient did not require any treatment for the reaction. The patient was reported to be doing good. The patient has no relevant pre-existing condition; however, the patient has sulfa, penicillin and thromycin allergies. The doctor did not make any adjustment to the nightguard. The patient only rinsed and cleaned the nightguard with water and sensodyne toothpaste.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011649314-2019-00132 |
| MDR Report Key | 8553198 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-04-25 |
| Date of Report | 2019-04-25 |
| Date of Event | 2019-03-18 |
| Date Mfgr Received | 2019-03-27 |
| Device Manufacturer Date | 2018-11-13 |
| Date Added to Maude | 2019-04-25 |
| 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. TOAN HOANG |
| Manufacturer Street | 2212 DUPONT DRIVE SUITE P |
| Manufacturer City | IRVINE CA 92612 |
| Manufacturer Country | US |
| Manufacturer Postal | 92612 |
| Manufacturer Phone | 9492251235 |
| Manufacturer G1 | PRISMATIK DENTALCRAFT, INC. |
| Manufacturer Street | 2212 DUPONT DRIVE SUITE P |
| Manufacturer City | IRVINE CA 92612 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92612 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EMA |
| Generic Name | ANTI-SNORING DEVICE, EMA |
| Product Code | LRK |
| Date Received | 2019-04-25 |
| Model Number | NI |
| Catalog Number | NI |
| Lot Number | NI |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PRISMATIK DENTALCRAFT, INC. |
| Manufacturer Address | 2212 DUPONT DRIVE SUITE P IRVINE CA 92612 US 92612 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-25 |