Brand Name | PRISMALIX |
Manufacturer (Section D) |
MAQUET SAS - ORLEANS -FRANCE |
|
|
Manufacturer (Section G) |
MAQUET SAS |
parc de limere |
avenue de la pomme de pin |
ardon, orleans cedex 2 4507 4 |
FR
45074
|
|
Manufacturer Contact |
janice
pevide
|
45 barbour pond dr |
wayne, NJ 07470
|
9737097753
|
|
MDR Report Key | 3868726 |
MDR Text Key | 15361371 |
Report Number | 9710055-2014-00031 |
Device Sequence Number | 1 |
Product Code |
FSY
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K040015 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility,Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
05/07/2014,02/18/2014 |
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 Model Number | PRX6000 |
Device Catalogue Number | 567237998 |
Other Device ID Number | 567216995 |
Was Device Available for Evaluation? |
Yes
|
Was the Report Sent to FDA? |
No
|
Distributor Facility Aware Date | 02/18/2014 |
Event Location |
Hospital
|
Initial Date Manufacturer Received |
02/18/2014
|
Initial Date FDA Received | 05/07/2014 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 06/01/2005 |
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 |
|
|