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 2019-02-18 for XTRA SILENT NITE manufactured by Prismatik Dentalcraft, Inc..
[136522993]
Patient's weight was asked but unknown. Request to have the device return was made; however, the device has not been returned for evaluation yet. Once the device is received and evaluation is completed, a supplemental report will be submitted. This report is for the lower tray of the night guard. Please reference 3011649314-2019-00012 ((b)(4)) for the upper tray.
Patient Sequence No: 1, Text Type: N, H10
[136522994]
This report is for the lower tray of the xtra silent nite: it was reported that a patient experienced an allergic reaction after using the xtra silent nite night guard. Originally, the night guard was made for patient under (case # (b)(4)); however, the lower tray was returned for remake for better fit. A new lower tray was sent to patient under (case # (b)(4)). The doctor also made some adjustments to the lower left buccal area on the outside of new lower tray. After using the night guard for about 2 weeks, the patient reported of an allergic reaction. The patient developed rash on the cheeks and the lower lip was swollen. Upon experiencing the reaction, the patient stopped using the night guard and did not resume use. The patient took benadryl to treat the reaction. The symptoms went away after a couple of days. The patient was reported to be doing fine. The patient has no pre-existing condition; however, the patient has skin sensitivity and allergic to some detergents and penicillin. The patient was recommended to clean the night guard with water.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011649314-2019-00013 |
| MDR Report Key | 8348864 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-02-18 |
| Date of Report | 2019-05-20 |
| Date of Event | 2018-12-10 |
| Date Mfgr Received | 2019-05-20 |
| Device Manufacturer Date | 2018-11-08 |
| Date Added to Maude | 2019-02-18 |
| 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 | 2019-02-18 |
| Returned To Mfg | 2019-03-15 |
| Model Number | NI |
| Catalog Number | NI |
| Lot Number | NI |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-02-18 |