| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | XTRA SILENT NITE | ANTI-SNORING NIGHTGUARD | PRISMATIK DENTALCRAFT, INC. | LRK | NI | NI | NI | Y | R |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-02-18 | 0 | 1. O |
Patient 1
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 1
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.