MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-14 for ASTRON CLEAR SPRINT manufactured by Prismatik Dentalcraft, Inc..
[175229165]
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. The patients weight is not provided as it is not taken at the time of the appointment. Is not applicable to this device with the exception of the lot number.
Patient Sequence No: 1, Text Type: N, H10
[175229166]
It was reported that the patient had a sore throat while wearing the astron clear splint. The patient has a history of thyroid disease for which she takes medication, but the specific med is not known at this time per the provider. She also has a history of cold sores (hsvi). The patient is allergic/sensitive to latex, metal and penicillin. The patient was presented with the device on (b)(6) 2019 with instructions on how to clean and care for the device. On (b)(6) 2019, the patient returned for adjustments. There were no complaints at that time. The patient returned for a general cleaning on (b)(6) 2019 and informed the hygienist that, "she had a sore throat that she believes was caused by the device. She also states that, she has a sensitivity to plastic. " the provider then decides to re-make the device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011649314-2019-00808 |
| MDR Report Key | 9588273 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-14 |
| Date of Report | 2020-01-14 |
| Date of Event | 2019-12-17 |
| Date Mfgr Received | 2019-12-17 |
| Date Added to Maude | 2020-01-14 |
| 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. 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 | ASTRON CLEAR SPRINT |
| Generic Name | THERMOFORM MOUTHGUARD |
| Product Code | MQC |
| Date Received | 2020-01-14 |
| 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 | 1. Required No Informationntervention | 2020-01-14 |