MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-16 for COMFORT HARD-SOFT SPLINT manufactured by Prismatik Dentalcraft, Inc..
[177579168]
The patients weight is not provided as it is not taken at the time of the appointment. The patient's race and ethnicity were not provided when asked. Not applicable to 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
[177579169]
It was reported that the patient had a reaction while wearing the comfort hard-soft device. The symptoms were as follows: swelling of lips, tongue, and mouth. The patient also noted a "hard time swallowing, burning, and tingling sensation. " the device was delivered to the patient on 12-16-2019. Instructions on how to care and store the device was provided to the patient. On (b)(6) 2019, the patient returned for an adjustment. There was no complaint of any reaction at that time. The patient purchased a tooth whitening product. The patient returned on (b)(6) 2019 with complaints of "swelling of lips, tongue, and mouth. " the patient also noted a "hard time swallowing, burning, and tingling sensation. " the patient had another appointment for cleaning on (b)(6) 2019. No new complaints noted. It is unclear if the patient continued to use the device. The patient had allergy testing on (b)(6) 2019 and the results provided no allergies with the exception of doxycycline, iodine and shellfish.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011649314-2019-00810 |
| MDR Report Key | 9598520 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-16 |
| Date of Report | 2020-01-16 |
| Date of Event | 2019-12-27 |
| Date Mfgr Received | 2019-12-27 |
| Device Manufacturer Date | 2019-12-14 |
| Date Added to Maude | 2020-01-16 |
| 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 SPLINT |
| Generic Name | THERMOFORM |
| Product Code | MQC |
| Date Received | 2020-01-16 |
| 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 | 2020-01-16 |