N
Patient 1
DEVICE EVALUATION IN PROGRESS; SUPPLEMENTAL REPORT WILL BE SUBMITTED AFTER ADDITIONAL INFORMATION HAS BEEN OBTAINED.
MAUDE MDR 8309741
- MDR report key
- 8309741
- Report number
- 9615892-2019-00002
- Event key
- 0
- Event type
- 3
- Date of event
- 2019-01-14
- Date received
- 2019-02-06
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 100
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MR. REINHARD WOLKERSTORFER
- Address
- BREHMSTRASSE 16 VIENNA, 1110 AU
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | GENIUM X3 | EXTERNAL ABOVE KNEE PROSTHESIS | OTTO BOCK HEALTHCARE PRODUCTS GMBH | ISY | 3B5-2 | 3B5-2 | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-02-06 | 0 | 1. H; 2. R |
Event Narratives#
D
Patient 1
KNEE CAUSED THE PATIENT TO FALL AND HIT HIS HEAD. PATIENT WAS CALLING PC ALL WEEKEND THAT KNEE KEPT GIVING CODE " YOU CAN USE THIS KNEE WITHOUT RESTRICTIONS". HEAD INJURY CONCUSSION.