Brand Name | FACTOR VIII CHROMOGENIC ASSAY |
Type of Device | FACTOR VIII CHROMOGENIC ASSAY |
Manufacturer (Section D) |
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
emil-von-behring-str. 76 |
marburg, D-350 41 |
GM D-35041 |
|
Manufacturer (Section G) |
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
emil-von-behring-str. 76 |
|
marburg, D-350 41 |
GM
D-35041
|
|
Manufacturer Contact |
christopher
aebig
|
511 benedict ave. |
tarrytown, NY 10591
|
9144153450
|
|
MDR Report Key | 14604885 |
MDR Text Key | 302280838 |
Report Number | 9610806-2022-00041 |
Device Sequence Number | 1 |
Product Code |
GGP
|
UDI-Device Identifier | 00842768004032 |
UDI-Public | 00842768004032 |
Combination Product (y/n) | N |
Reporter Country Code | FI |
PMA/PMN Number | K884544 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,User Facility |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
06/06/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 02/21/2023 |
Device Model Number | FACTOR VIII CHROMOGENIC ASSAY |
Device Catalogue Number | 10445729 |
Device Lot Number | 00199 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
05/12/2022
|
Initial Date FDA Received | 06/06/2022 |
Was Device Evaluated by Manufacturer? |
No
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
Patient Age | 1 YR |