MAUDE MDR 9744713
- MDR report key
- 9744713
- Report number
- 3011649314-2020-00474
- Event key
- 0
- Event type
- 3
- Date received
- 2020-02-24
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 116
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Devices#
Seq, Brand, Generic table| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|
| 1 | COMFORT HARD-SOFT BITE SPLINT? | THERMOFORM MOUTHGUARD | PRISMATIK DENTALCRAFT, INC. | MQC | | | | | | | N
| N |
Patients#
Sequence, Received, Treatment table| Sequence | Received | Treatment | Outcome |
|---|
| 1 | 2020-02-24 | 0 | 1. R
|
Event Narratives#
No narrative records found.