Brand Name | GENIUM X3 |
Type of Device | EXTERNAL ABOVE KNEE PROSTHESIS |
Manufacturer (Section D) |
OTTO BOCK HEALTHCARE PRODUCTS GMBH |
brehmstrasse 16 |
vienna, 1110 |
AU 1110 |
|
MDR Report Key | 7572793 |
MDR Text Key | 110177333 |
Report Number | 9615892-2018-00015 |
Device Sequence Number | 1 |
Product Code |
ISY
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,health profession |
Type of Report
| Initial,Followup |
Report Date |
06/25/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 06/06/2018 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Lay User/Patient
|
Device Model Number | 3B5-2 |
Device Catalogue Number | 3B5-2 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 06/08/2018 |
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 06/20/2018 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|
|
|