MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-20 for COMFORT HARD-SOFT BITE SPLINT manufactured by Prismatik Dentalcraft, Inc..
[176076388]
The device has not yet been returned. An investigation will be conducted once the sample has been returned and a supplemental report will be submitted. Age - asked, but unknown. Date of birth - asked, but unknown. Weight- asked, but unknown. Ethnicity - asked, but unknown. Race - asked, but unknown. Date of event - asked, but unknown. Model number - not applicable. Section d4/catalog number - not applicable. Lot number - not applicable. Expiration date - not applicable. Udi number - not available. Email - not available.
Patient Sequence No: 1, Text Type: N, H10
[176076389]
It was reported that a patient experienced an unknown allergic reaction after using a comfort hard-soft bite splint (upper). It is unknown whether or not the patient has any known allergies.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011649314-2020-00005 |
| MDR Report Key | 9608533 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-20 |
| Date of Report | 2020-01-20 |
| Date Mfgr Received | 2020-01-08 |
| Device Manufacturer Date | 2019-09-09 |
| Date Added to Maude | 2020-01-20 |
| 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 BITE SPLINT |
| Generic Name | THERMOFORM MOUTHGUARD |
| Product Code | MQC |
| Date Received | 2020-01-20 |
| 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 | 2020-01-20 |