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 COMFORT HARD-SOFT BITE SPLINT NI manufactured by Prismatik Dentalcraft, Inc..
[142182995]
The reported mouthguard has not been available for evaluation yet. Once the investigation is completed, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[142182996]
It was reported that a patient experienced an allergic reaction after wearing a comfort hard-soft bite splint overnight. The patient had been using the mouthguard for about 2 weeks before experiencing the issue. The patient's lips felt numb on the area where made contact with the mouthguard. Upon experiencing the reaction, the patient stopped using the mouthguard and the numb feeling went away after a day. The patient did not require any treatment for the reaction. The patient was reported to be doing fine. The patient was prescribed the mouthguard for severe bruxism. The patient has a history of high blood pressure. The patient has no known allergy. The doctor made adjustment to the right side (both inside and outside) of the mouthguard. The patient cleaned the mouthguard using only water.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011649314-2019-00069 |
| MDR Report Key | 8521065 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-04-16 |
| Date of Report | 2019-07-17 |
| Date of Event | 2019-03-07 |
| Date Mfgr Received | 2019-07-16 |
| Device Manufacturer Date | 2019-02-20 |
| 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 | COMFORT HARD-SOFT BITE SPLINT |
| Generic Name | THERMOFORMED MOUTHGUARD, COMFORT 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 Age | DA |
| 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 |