MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-10 for XTRA SILENT NITE manufactured by Prismatik Dentalcraft, Inc..
[180571963]
The device has not yet been returned. An investigation will be conducted once the sample has been returned and a supplemental report will be submitted. Weight: asked, but unknown. Date of event: asked, but unknown. Model number: not applicable. Catalog number: not applicable. Lot number: not applicable. Expiration date: not applicable. Udi number: not available.
Patient Sequence No: 1, Text Type: N, H10
[180571964]
It was reported that a patient experienced an allergic reaction after using an xtra silent nite slide link appliance. According to the information provided by the doctor, the patient experienced swelling on the lips overnight on unknown date. It is unknown whether or not the patient has any known allergies.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011649314-2019-00807 |
| MDR Report Key | 9575563 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-10 |
| Date of Report | 2020-01-10 |
| Date Mfgr Received | 2019-12-13 |
| Device Manufacturer Date | 2019-12-05 |
| Date Added to Maude | 2020-01-10 |
| 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. HERBERT SCHOENHOEFER |
| Manufacturer Street | 2212 DUPONT DRIVE SUITE P |
| Manufacturer City | IRVINE CA 92612 |
| Manufacturer Country | US |
| Manufacturer Postal | 92612 |
| Manufacturer Phone | 9494402632 |
| Manufacturer G1 | PRISMATIK DENTALCRAFT, INC. |
| Manufacturer Street | 2212 DUPONT DR 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 | 2020-01-10 |
| 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. Required No Informationntervention | 2020-01-10 |