MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-24 for ASTRON CLEAR SPLINTS? manufactured by Prismatik Dentalcraft, Inc..
[180637332]
Not applicable for this device with the exception of the lot number and the operator of the device. This is the first of two implant complaints, see manufacturer report for the remaining complaint: 3011649314-2020-00474 ((b)(4).
Patient Sequence No: 1, Text Type: N, H10
[180637333]
It was reported that the patient experienced a reaction after wearing the astron clear splint. The provider notes, "patient experienced sores on upper lip where there was contact. However, the provider thought may be a dry mouth concern. The provider advised the patient to moisturize area, but reaction continued. The patient instructed the patient to stop use of the device. " the device will be returned.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011649314-2020-00473 |
| MDR Report Key | 9744731 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-24 |
| Date of Report | 2020-02-24 |
| Date Mfgr Received | 2020-01-22 |
| Device Manufacturer Date | 2020-01-13 |
| Date Added to Maude | 2020-02-24 |
| 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 |
| Manufacturer Country | US |
| Manufacturer Phone | 4402632 |
| Manufacturer G1 | PRISMATIK DENTALCRAFT, INC. |
| Manufacturer Street | 2212 DUPONT DR SUITE P |
| Manufacturer City | IRVINE, CA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ASTRON CLEAR SPLINTS? |
| Generic Name | ASTRON CLEAR SPLINTS? |
| Product Code | MQC |
| Date Received | 2020-02-24 |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-24 |