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 2019-06-12 for XTRA SILENT NITE manufactured by Prismatik Dentalcraft, Inc..
[147773406]
Follow-up was made to ask for nightguard return for evaluation; however, the patient decided not to send the nightguard back. Once the evaluation is completed, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[147773407]
It was reported that a patient experienced an allergic reaction after using the xtra silent nite nightguard. The patient has had the nightguard for a while; however, the patient reported to wear the nightguard only when she was on a trip or vacation. During a trip, the patient experienced the reaction on the 2nd day of wearing the nightguard. The patient's mouth was reported to be swollen, tongue got "fat" and felt like having a rash. Upon experiencing the reaction, the patient stopped using the nightguard and the reaction lasted for 2 to 3 days. To treat the symptom, the patient rinsed with nystatin. The patient reported to be doing good. While the patient has no pre-existing condition, the patient reported to be allergic to wool. The doctor did not make any adjustment to the nightguard. The nightguard was rinsed with water prior delivering to the patient. The patient cleaned the nightguard using dawn dish soap.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011649314-2019-00174 |
| MDR Report Key | 8692664 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-06-12 |
| Date of Report | 2019-10-28 |
| Date Mfgr Received | 2019-10-23 |
| Device Manufacturer Date | 2017-12-28 |
| Date Added to Maude | 2019-06-12 |
| 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. 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 | XTRA SILENT NITE |
| Generic Name | ANTI-SNORING NIGHTGUARD |
| Product Code | LRK |
| Date Received | 2019-06-12 |
| Model Number | NI |
| Catalog Number | NI |
| Lot Number | NI |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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; 2. Required No Informationntervention | 2019-06-12 |