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 2019-05-22 for XTRA SILENT NITE manufactured by Prismatik Dentalcraft, Inc..
[145836182]
Date of event was asked, and it was advised to be some time in (b)(6) 2019. Request was made to have the reported nightguard return for evaluation; however, the nightguard has not been returned as of late. Once the evaluation is completed, a supplemental report will be submitted. This report is for the 3rd of 3 reported events: please reference 3011649314-2019-00162 ((b)(4)) for the 1st event. Please reference 3011649314-2019-00169 ((b)(4)) for the 2nd event.
Patient Sequence No: 1, Text Type: N, H10
[145836183]
This report is for the 3rd event: after the patient resumed use of a silent night nightguard, it was reported that "once again same symptoms occurred, only this time my lips were slightly inflamed, same irritation at the corners of my mouth, my tongue started looking very fissured and red. My gums got really red and puffy/inflamed and i felt that i had a funny film (or sensation of film) in my mouth. " the reaction continued for the entire time the patient wore the appliance (approx. 1 week). The patient reported that they stopped everything and it gradually went away. The patient did not require any treatment for the reaction. The patient was reported to be doing better now. The patient has history of hodgkin's lymphoma (treated with chemo and radiation) and currently taking levothyroxine. The patient also has penicillin and brazil nuts allergies. No adjustment was made to the nightguard. The nightguard was cleaned using only water and toothbrush. No disinfectant was used.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011649314-2019-00170 |
| MDR Report Key | 8633229 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-05-22 |
| Date of Report | 2019-09-19 |
| Date of Event | 2019-04-01 |
| Date Mfgr Received | 2019-08-22 |
| Device Manufacturer Date | 2019-03-15 |
| Date Added to Maude | 2019-05-22 |
| 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 | 2019-05-22 |
| Returned To Mfg | 2019-07-03 |
| 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 | 2019-05-22 |