Brand Name | EMBOSPHERE MICROSPHERES |
Manufacturer (Section D) |
BIOSPHERE MEDICAL, S.A. |
nord 2 383 rue de la belle |
roissy-en-france |
FR |
|
Manufacturer Contact |
alix
fonlladosa
|
parc de nations, paris nord 2 |
383, rue de la belle etoile |
roissy en france ch de gaulle cede 95 70-0
|
FR
95 700
|
48172529
|
|
MDR Report Key | 4638873 |
MDR Text Key | 5613851 |
Report Number | 9615728-2015-00003 |
Device Sequence Number | 1 |
Product Code |
NAJ
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K021397 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Company Representative,Distributor |
Reporter Occupation |
Not Applicable
|
Type of Report
| Initial |
Report Date |
01/30/2015 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 02/26/2015 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 11/30/2017 |
Device Model Number | S220GH |
Device Catalogue Number | S220GH |
Device Lot Number | X2723999 |
Was Device Available for Evaluation? |
Yes
|
Date Returned to Manufacturer | 02/02/2015 |
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 01/30/2015 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 12/01/2014 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
|
|