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 2019-05-14 for COMFORT HARD-SOFT BITE SPLINT NI manufactured by Prismatik Dentalcraft, Inc..
[145114813]
The device was received and the evaluation is anticipated. Once the investigation is completed, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[145114814]
It was reported that a patient experienced an allergic reaction shortly after wearing the comfort hard-soft bite splint. After wearing the mouthguard for 20 minutes on the first use, the patient reported feeling tingling and numbing on the tip of the tongue and on the lips, where they made contact with the mouthguard. Upon experiencing the reaction, the patient stopped using the mouthguard immediately. The symptoms went away completely after 24 hours. The patient did not require any treatment for the reaction. The patient reported to be doing ok. The patient has no pre-existing condition; however, the patient has a history of sensitivity and chemical allergies (hydroxyethylmethacrylate or hema, quaternium-15, isoeugenol, latex). The doctor did not make any adjustment to the mouthguard prior delivering to the patient. The mouthguard was cleaned with water.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011649314-2019-00149 |
| MDR Report Key | 8610381 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-05-14 |
| Date of Report | 2019-08-14 |
| Date of Event | 2019-03-20 |
| Date Mfgr Received | 2019-08-13 |
| Device Manufacturer Date | 2019-03-11 |
| Date Added to Maude | 2019-05-14 |
| 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 SPLINTS |
| Product Code | MQC |
| Date Received | 2019-05-14 |
| Returned To Mfg | 2019-04-29 |
| Model Number | NI |
| Catalog Number | NI |
| Lot Number | NI |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-05-14 |