MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-10 for SEMI-HARD NIGHTGUARD manufactured by Prismatik Dentalcraft, Inc..
[178747521]
Age or date of birth: information not provided when requested. Weight: information not provided when requested. Date of event: information not provided when requested. Relevant tests/other relevant history: information not provided when requested. Lot#: not applicable for this device with the exception of the lot 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
[178747522]
It was reported that the patient developed a itchiness in the mouth. There is no other information provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011649314-2020-00446 |
| MDR Report Key | 9687344 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-10 |
| Date of Report | 2020-02-10 |
| Date Mfgr Received | 2020-01-17 |
| Device Manufacturer Date | 2017-03-15 |
| Date Added to Maude | 2020-02-10 |
| 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 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 | SEMI-HARD NIGHTGUARD |
| Generic Name | SEMI-HARD NIGHTGUARD |
| Product Code | MQC |
| Date Received | 2020-02-10 |
| 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 | 2020-02-10 |