MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-06 for COMFORT HARD-SOFT BITE SPLINT manufactured by Prismatik Dentalcraft, Inc..
[177992450]
The patients weight is not provided as it is not taken at the time of the appointment. Date of event is unknown when asked this section is not applicable for this device. With the exception of the serial number. The device has not been returned. If/when the device is returned an investigation will be carried out and a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[177992451]
It was reported that the patient had a possible allergic reaction to the night guard. The provider notes that the patient felt the device is causing a sore throat. The patient has allergies to latex and metals, but it is not known which metals the patient is allergic to. The provider also notes the patient has food allergies, but was not specific when asked. It is unclear when the reaction to the device occurred, only that it happened shortly after use. The patient discontinued use of the device when the reaction occurred. The patient was provided care and storage instructions when the device was delivered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011649314-2020-00445 |
| MDR Report Key | 9676041 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-06 |
| Date of Report | 2020-02-06 |
| Date Mfgr Received | 2020-01-16 |
| Device Manufacturer Date | 2019-11-20 |
| Date Added to Maude | 2020-02-06 |
| 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. HERBERT SCHOENHOEFER |
| Manufacturer Street | 2212 DUPONT DRIVE SUITE P |
| Manufacturer City | IRVINE CA 92612 |
| Manufacturer Country | US |
| Manufacturer Postal | 92612 |
| Manufacturer Phone | 9494402632 |
| Manufacturer G1 | PRISMATIK DENTALCRAFT, INC. |
| Manufacturer Street | 2212 DUPONT DR 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 | THERMOFORM MOUTHGUARD |
| Product Code | MQC |
| Date Received | 2020-02-06 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | NA |
| 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 | 2020-02-06 |