MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-12-10 for COMFORT HARD-SOFT BITE SPLINT manufactured by Prismatik Dentalcraft Inc..
[170113919]
The device has not yet been returned. An investigation will be conducted once the sample has been returned and a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[170113920]
It was reported that a patient experienced an unknown allergic reaction after using a comfort hard-soft splint (upper) appliance. According to the information provided by the doctor, the patient experienced the allergic reaction on the tongue. The patient believes that the allergic reaction was caused by the device/appliance. The patient declined sending the device back for credit and/or evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011649314-2019-00764 |
| MDR Report Key | 9444864 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-12-10 |
| Date of Report | 2020-03-18 |
| Date Mfgr Received | 2020-03-06 |
| Device Manufacturer Date | 2019-06-22 |
| Date Added to Maude | 2019-12-10 |
| 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 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 | THERMOFORM MOUTHGUARD |
| Product Code | MQC |
| Date Received | 2019-12-10 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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. Required No Informationntervention | 2019-12-10 |