Brand Name | COAGULATION FACTOR VIII DEFICIENT PLASMA |
Type of Device | COAGULATION FACTOR VIII DEFICIENT PLASMA |
Manufacturer (Section D) |
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
emil von behring strasse 76 |
marburg, 35041 |
GM 35041 |
|
Manufacturer (Section G) |
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
emil von behring strasse 76 |
|
marburg, 35041 |
GM
35041
|
|
Manufacturer Contact |
loriann
russo
|
511 benedict avenue |
tarrytown, NY 10591
|
9145242287
|
|
MDR Report Key | 7165793 |
MDR Text Key | 97477162 |
Report Number | 9610806-2018-00003 |
Device Sequence Number | 1 |
Product Code |
GJT
|
UDI-Device Identifier | 00842768010996 |
UDI-Public | 00842768010996 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K924396 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,user faci |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial |
Report Date |
01/04/2018 |
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 | 10/20/2018 |
Device Catalogue Number | 10446411 |
Device Lot Number | 547642A |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
12/09/2017
|
Initial Date FDA Received | 01/04/2018 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 11/03/2016 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |