Brand Name | DATE(R) ACTIN(R) ACTIVATED CEPHALOPLASTIN REAGENT |
Type of Device | DATE(R) ACTIN(R) ACTIVATED CEPHALOPLASTIN REAGENT, |
Manufacturer (Section D) |
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
76 emil von behring strasse |
marburg, 35041 |
GM 35041 |
|
Manufacturer (Section G) |
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
76 emil von behring strasse |
|
marburg, 35041 |
GM
35041
|
|
Manufacturer Contact |
james
morgera
|
glasgow business community |
po box 6101 |
newark, DE 19714-6101
|
3026318356
|
|
MDR Report Key | 5430152 |
MDR Text Key | 37993704 |
Report Number | 9610806-2016-00010 |
Device Sequence Number | 1 |
Product Code |
GFO
|
Combination Product (y/n) | N |
Reporter Country Code | UK |
PMA/PMN Number | K760318 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,u |
Reporter Occupation |
Medical Technologist
|
Remedial Action |
Recall |
Type of Report
| Initial |
Report Date |
03/10/2015 |
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 |
Medical Technologist
|
Device Expiration Date | 02/16/2016 |
Device Catalogue Number | B4218-1 |
Device Lot Number | 557140 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
03/10/2015 |
Initial Date FDA Received | 02/11/2016 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 08/21/2015 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Removal/Correction Number | 9610806-03-24-2015-002-C |
Patient Sequence Number | 1 |