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 2019-04-16 for ASTRON CLEARSPLINTS NI manufactured by Prismatik Dentalcraft, Inc..
[142181410]
Date of event was advised to be (b)(6) 2019; however, specific date was unknown. Patient's weight was asked but unknown. Follow-up attempts were made to request nightguard back for evaluation; however, the nightguard has not been returned yet. Once the nightguard is returned and evaluation is completed, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[142181411]
It was reported that a patient experienced an allergic reaction after using an astron clearsplints nightguard. After wearing the nightguard for 1 to 2 weeks, the patient developed swollen lips and soreness/tenderness on the teeth and gums. Upon experiencing the reaction, the patient stopped using the nightguard right away. The symptoms were cleared after about a day. The patient did not require any treatment for the symptoms. The patient reported to be doing ok when she visited the clinic. The patient has no medical pre-existing condition or allergy; however, she has a history of heavy bruxism. The doctor did not make any adjustment to the nightguard. The patient was instructed to clean the nightguard only using water.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011649314-2019-00068 |
| MDR Report Key | 8521064 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-04-16 |
| Date of Report | 2019-12-02 |
| Date of Event | 2019-02-01 |
| Date Mfgr Received | 2019-10-17 |
| Device Manufacturer Date | 2019-01-14 |
| Date Added to Maude | 2019-04-16 |
| 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 | ASTRON CLEARSPLINTS |
| Generic Name | NIGHTGUARD, ASTRON SPLINT |
| Product Code | MQC |
| Date Received | 2019-04-16 |
| Model Number | NI |
| Catalog Number | NI |
| Lot Number | NI |
| 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. Other | 2019-04-16 |