MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-01-17 for MOUTHGUARD manufactured by Prismatik Dentalcraft, Inc..
[176615021]
Patient demographics not provided. Device information not provided. 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
[176615022]
Received a report from the fda (mw5091589) regarding a new event. It was reported that a patient had an allergic reaction after using a mouthguard. The report notes, "tongue and gums burning, a sore throat occurs only when using night guard. Resolves with discontinued use. " the date of event is noted as (b)(6) 2018. The patient has a medication history of levothyroxine, estrogen, progesterone, multivitamin, vitamin d, mag citrate and k citrate. No other information provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011649314-2020-00001 |
| MDR Report Key | 9603566 |
| Report Source | CONSUMER |
| Date Received | 2020-01-17 |
| Date of Report | 2020-01-17 |
| Date of Event | 2018-08-01 |
| Date Mfgr Received | 2019-12-27 |
| Date Added to Maude | 2020-01-17 |
| 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 |
| 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 | MOUTHGUARD |
| Generic Name | MOUTHGUARD |
| Product Code | MQC |
| Date Received | 2020-01-17 |
| 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 | 2020-01-17 |