MAUDE MDR 9391993
- MDR report key
- 9391993
- Report number
- 9610905-2019-00227
- Event key
- 0
- Event type
- 3
- Date of event
- 2019-11-01
- Date received
- 2019-11-29
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MS. JENNIFER DAMATO
- Address
- P.O. BOX 16369 JACKSONVILLE FL 32245 US
- Phone
- 904-904-9046
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | LEVEL ONE CMF | PLATE | KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG | MQN | 50-731-06-09 | UNKNOWN | N | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-11-29 | 0 | 1. O |
Event Narratives#
No narrative records found.