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 COMFORT HARD-SOFT SPLINT UPPER manufactured by Prismatik Dentalcraft, Inc..
[175020368]
The device has not been returned. If/when the device is returned an investigation of the device 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. Not applicable for this device with the exception of the lot number.
Patient Sequence No: 1, Text Type: N, H10
[175020369]
It was reported that the patient had swelling and pain while wearing comfort hard-soft splint. The patient is allergic to penicillin. The patient was given care instructions at the initial visit. There are no other allergies or sensitivities noted by provider. The patient reported that she only cleaned the device with water. It was also reported that the patient presented with the device almost monthly (after delivery) with complaints of pain and swelling of the lips. The specific dates could not be provided. However, in (b)(6) 2019, the patient returned for general cleaning and informed the hygienist that, "she had a swelling around the lips and pain to the gums after the 2nd or 3rd night of wear. " the patient tried to continue to wear it, but was unable to do so after the 3rd day. The patient returned in (b)(6) 2019 with the same complaints. The patient discontinued using the device in december.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011649314-2019-00809 |
| MDR Report Key | 9588272 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-14 |
| Date of Report | 2020-01-14 |
| Date of Event | 2019-10-01 |
| Date Mfgr Received | 2019-12-17 |
| Device Manufacturer Date | 2015-10-10 |
| 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 | COMFORT HARD-SOFT SPLINT UPPER |
| Generic Name | THERMOFORM MOUTHGUARD |
| Product Code | MQC |
| Date Received | 2020-01-14 |
| 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 |