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..
[145837933]
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 1st of 3 reported events: please reference 3011649314-2019-00169 ((b)(4)) for the 2nd event. Please reference 3011649314-2019-00170 ((b)(4)) for the 3rd event.
Patient Sequence No: 1, Text Type: N, H10
[145837934]
This report is for the 1st event: it was reported that a patient experienced an allergic reaction after using the xtra silent nite nightguard. On the first night of use, the patient experienced slightly swollen lips and some irritation at the corners of the mouth ("similar to angular cheilitis". ) after a few more nights of use the patient's tongue was slightly inflamed and gums were very red, by morning. Upon experiencing the reaction, the patient stopped using the nightguard for a couple of weeks and "everything settled down to normal". The patient resumed use after a couple of weeks off and the same irritation on the corners of the mouth occurred, along with lips that were slightly inflamed. The patient reported that the tongue started looking very "fissured and red, gums got really red and puffy/inflamed, felt like i had a funny film or sensation of film in my mouth. " this reaction was experienced for the entire time the appliance was worn (approx. 1 week). Once the patient stopped all use of the product, "everything gradually went away. " the patient did not require any treatment for the reaction. The patient has history of hodgkin's lymphoma (treated with chemo and radiation) and currently taking levothyroxine. The patient also has penicillin and brazil nut allergies. No adjustment was made to the nightguard. The nightguard was cleaned using only water and a toothbrush. No disinfectant was used.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011649314-2019-00162 |
| MDR Report Key | 8633234 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-05-22 |
| Date of Report | 2019-09-19 |
| Date of Event | 2019-03-18 |
| 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 |