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 2019-05-02 for COMFORT HARD-SOFT BITE SPLINT NI manufactured by Prismatik Dentalcraft, Inc..
[143936492]
The reported device was sent and pending to be received. Once the device is received and evaluation is completed, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[143936493]
It was reported that a patient experienced an allergic reaction after using a comfort hard-soft bite splint. On the 3rd day of using the mouthguard, the patient developed blisters, swelling, irritation and redness all around the mouth. Upon experiencing the reaction, the patient stopped using the mouthguard. The reaction went away after 2 days. The patient did not require any treatment for the reaction. The patient was reported to be doing fine. The patient is very sensitive and has many allergies including grass and certain foods. The patient has no relevant medical pre-existing condition. The doctor made adjustment to the occlusal side on the mouthguard's upper right. The patient was recommended to clean the mouthguard using soap and brushes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011649314-2019-00139 |
| MDR Report Key | 8575888 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-05-02 |
| Date of Report | 2019-07-31 |
| Date of Event | 2019-03-22 |
| Date Mfgr Received | 2019-07-31 |
| Device Manufacturer Date | 2019-03-12 |
| Date Added to Maude | 2019-05-02 |
| 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 | 2019-05-02 |
| 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 | 2019-05-02 |